82_FR_53195
82 FR 52976 - Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program
82 FR 52976 - Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services
Federal Register Volume 82, Issue 219 (November 15, 2017)
Page Range
52976-53371
FR Document
2017-23953
This major final rule addresses changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies such as changes to the Medicare Shared Savings Program, to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. In addition, this final rule includes policies necessary to begin offering the expanded Medicare Diabetes Prevention Program model.
Federal Register, Volume 82 Issue 219 (Wednesday, November 15, 2017)
[Federal Register Volume 82, Number 219 (Wednesday, November 15, 2017)]
[Rules and Regulations]
[Pages 52976-53371]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-23953]
[[Page 52975]]
Vol. 82
Wednesday,
No. 219
November 15, 2017
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 405, 410, 414, et al.
Medicare Program; Revisions to Payment Policies Under the Physician Fee
Schedule and Other Revisions to Part B for CY 2018; Medicare Shared
Savings Program Requirements; and Medicare Diabetes Prevention Program;
Final Rule
Federal Register / Vol. 82 , No. 219 / Wednesday, November 15, 2017 /
Rules and Regulations
[[Page 52976]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 405, 410, 414, 424, and 425
[CMS-1676-F]
RIN 0938-AT02
Medicare Program; Revisions to Payment Policies Under the
Physician Fee Schedule and Other Revisions to Part B for CY 2018;
Medicare Shared Savings Program Requirements; and Medicare Diabetes
Prevention Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
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SUMMARY: This major final rule addresses changes to the Medicare
physician fee schedule (PFS) and other Medicare Part B payment policies
such as changes to the Medicare Shared Savings Program, to ensure that
our payment systems are updated to reflect changes in medical practice
and the relative value of services, as well as changes in the statute.
In addition, this final rule includes policies necessary to begin
offering the expanded Medicare Diabetes Prevention Program model.
DATES: These regulations are effective on January 1, 2018.
FOR FURTHER INFORMATION CONTACT: Jessica Bruton, (410) 786-5991, for
any physician payment issues not identified below.
Lindsey Baldwin, (410) 786-1694, and Emily Yoder, (410) 786-1804,
for issues related to telehealth services and primary care.
Roberta Epps, (410) 786-4503, for issues related to PAMA section
218(a) policy and transition from traditional X-ray imaging to digital
radiography.
Isadora Gil, (410) 786-4532, for issues related to the valuation of
cardiovascular services, bone marrow services, surgical respiratory
services, dermatological procedures, and payment rates for nonexcepted
items and services furnished by nonexcepted off-campus provider-based
departments of a hospital.
Donta Henson, (410) 786-1947, for issues related to ophthalmology
services.
Jamie Hermansen, (410) 786-2064, for issues related to the
valuation of anesthesia services.
Tourette Jackson, (410) 786-4735, for issues related to the
valuation of musculoskeletal services, allergy and clinical immunology
services, endocrinology services, genital surgical services, nervous
system services, INR monitoring services, injections and infusions, and
chemotherapy services.
Ann Marshall, (410) 786-3059, for issues related to primary care,
chronic care management (CCM), and evaluation and management (E/M)
services.
Geri Mondowney, (410) 786-1172, for issues related to malpractice
RVUs.
Patrick Sartini, (410) 786-9252, for issues related to the
valuation of imaging services and malpractice RVUs.
Michael Soracoe, (410) 786-6312, for issues related to the practice
expense methodology, impacts, conversion factor, and valuation of
pathology and surgical procedures.
Pamela West, (410) 786-2302, for issues related to therapy
services.
Corinne Axelrod, (410) 786-5620, for issues related to rural health
clinics or federally qualified health centers.
Felicia Eggleston, (410) 786-9287, for issues related to DME
infusion drugs.
Rasheeda Johnson, (410) 786-3434, for issues related to initial
data collection and reporting periods for the clinical laboratory fee
schedule.
Edmund Kasaitis, (410) 786-0477, for issues related to biosimilars.
JoAnna Baldwin, (410) 786-7205, or Sarah Fulton, (410) 786-2749,
for issues related to appropriate use criteria for advanced diagnostic
imaging services.
Crystal Kellam, (410) 786-7970, for issues related to physician
quality reporting system.
Alesia Hovatter, (410) 786-6861, for issues related to Physician
Compare.
Alexandra Mugge, (410) 786-4457, for issues related to the EHR
incentive program.
Kari Vandegrift, (410) 786-4008, or [email protected], for issues
related to the Medicare Shared Savings Program.
Kimberly Spalding Bush, (410) 786-3232, or Fiona Larbi, (410) 786-
7224, for issues related to Value-based Payment Modifier and Physician
Feedback Program.
Wilfred Agbenyikey, (410) 786-4399, for issues related to MACRA
patient relationship categories and codes.
Carlye Burd, (410) 786-1972, or Albert Wesley, (410) 786-4204, for
issues related to the Medicare Diabetes Prevention Program expanded
model.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
II. Provisions of the Proposed Rule and Analysis of and Responses to
Public Comments
A. Background
B. Determination of Practice Expense (PE) Relative Value Units
(RVUs)
C. Determination of Malpractice Relative Value Units (RVUs)
D. Medicare Telehealth Services
E. Potentially Misvalued Services Under the PFS
F. Payment Incentive for the Transition from Traditional X-Ray
Imaging to Digital Radiography and Other Imaging Services
G. Establishment of Payment Rates Under the Medicare PFS for
Nonexcepted Items and Services Furnished by Nonexcepted Off-Campus
Provider-Based Departments of a Hospital
H. Valuation of Specific Codes
I. Evaluation & Management (E/M) Guidelines and Care Management
Services
J. Therapy Caps
III. Other Provisions of the Proposed Rule
A. New Care Coordination Services and Payment for Rural Health
Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)
B. Part B Drug Payment: Infusion Drugs Furnished Through an Item
of Durable Medical Equipment (DME)
C. Solicitation of Public Comments on Initial Data Collection
and Reporting Periods for Clinical Laboratory Fee Schedule
D. Payment for Biosimilar Biological Products Under Section
1847A of the Act
E. Appropriate Use Criteria for Advanced Diagnostic Imaging
Services
F. Physician Quality Reporting System Criteria for Satisfactory
Reporting for Individual EPs and Group Practices for the 2018 PQRS
Payment Adjustment
G. Clinical Quality Measurement for Eligible Professionals
Participating in the Electronic Health Record (EHR) Incentive
Program for 2016
H. Medicare Shared Savings Program
I. Value-Based Payment Modifier and Physician Feedback Program
J. MACRA Patient Relationship Categories and Codes
K. Changes to the Medicare Diabetes Prevention Program (MDPP)
Expanded Model
L. Physician Self-Referral Law: Annual Update to the List of
CPT/HCPCS Codes
IV. Collection of Information Requirements
V. Regulatory Impact Analysis
Regulations Text
Acronyms
In addition, because of the many organizations and terms to which
we refer by acronym in this final rule, we are listing these acronyms
and their corresponding terms in alphabetical order below:
A1c Hemoglobin A1c
AAA Abdominal aortic aneurysms
ABLE Achieving a Better Life Experience Act of 2014 (Pub. L. 113-
295)
ACI Advancing Care Information
ACO Accountable care organization
AMA American Medical Association
APM Alternative Payment Model
ASC Ambulatory surgical center
ATA American Telehealth Association
ATRA American Taxpayer Relief Act (Pub. L. 112-240)
AUC Appropriate Use Criteria
[[Page 52977]]
AWV Annual wellness visit
BBA Balanced Budget Act of 1997 (Pub. L. 105-33)
BBRA [Medicare, Medicaid and State Child Health Insurance Program]
Balanced Budget Refinement Act of 1999 (Pub. L. 106-113)
BHI Behavioral health integration
BLS Bureau of Labor Statistics
CAD Coronary artery disease
CAH Critical access hospital
CBSA Core-Based Statistical Area
CCM Chronic care management
CDSM Clinical Decision Support Mechanism
CEHRT Certified EHR technology
CF Conversion factor
CG-CAHPS Clinician and Group Consumer Assessment of Healthcare
Providers and Systems
CLFS Clinical Laboratory Fee Schedule
CoA Certificate of Accreditation
CoC Certificate of Compliance
CoCM Collaborative care model
CoR Certificate of Registration
CNM Certified nurse-midwife
CP Clinical psychologist
CPC Comprehensive Primary Care
CPEP Clinical Practice Expert Panel
CPT [Physicians] Current Procedural Terminology (CPT codes,
descriptions and other data only are copyright 2015 American Medical
Association. All rights reserved.)
CQM Clinical quality measure
CSW Clinical social worker
CT Computed tomography
CW Certificate of Waiver
CY Calendar year
DFAR Defense Federal Acquisition Regulations
DHS Designated health services
DM Diabetes mellitus
DSMT Diabetes self-management training
eCQM Electronic clinical quality measures
ED Emergency Department
EHR Electronic health record
E/M Evaluation and management
EMT Emergency Medical Technician
EP Eligible professional
eRx Electronic prescribing
ESRD End-stage renal disease
FAR Federal Acquisition Regulations
FDA Food and Drug Administration
FFS Fee-for-service
FQHC Federally qualified health center
FR Federal Register
FSHCAA Federally Supported Health Centers Assistance Act
GAF Geographic adjustment factor
GAO Government Accountability Office
GPCI Geographic practice cost index
GPO Group purchasing organization
GPRO Group practice reporting option
GTR Genetic Testing Registry
HCPCS Healthcare Common Procedure Coding System
HHS [Department of] Health and Human Services
HOPD Hospital outpatient department
HPSA Health professional shortage area
IDTF Independent diagnostic testing facility
IPPE Initial preventive physical exam
IPPS Inpatient Prospective Payment System
IQR Inpatient Quality Reporting
ISO Insurance service office
IT Information technology
IWPUT Intensity of work per unit of time
LCD Local coverage determination
MA Medicare Advantage
MAC Medicare Administrative Contractor
MACRA Medicare Access and CHIP Reauthorization Act of 2015 (Pub. L.
114-10)
MAP Measure Applications Partnership
MAPCP Multi-payer Advanced Primary Care Practice
MAV Measure application validity [process]
MCP Monthly capitation payment
MedPAC Medicare Payment Advisory Commission
MEI Medicare Economic Index
MFP Multi-Factor Productivity
MIPPA Medicare Improvements for Patients and Providers Act (Pub. L.
110-275)
MIPS Merit-based Incentive Payment System
MMA Medicare Prescription Drug, Improvement and Modernization Act of
2003 (Pub. L. 108-173, enacted on December 8, 2003)
MP Malpractice
MPPR Multiple procedure payment reduction
MRA Magnetic resonance angiography
MRI Magnetic resonance imaging
MSA Metropolitan Statistical Areas
MSPB Medicare Spending per Beneficiary
MU Meaningful use
NCD National coverage determination
NCQDIS National Coalition of Quality Diagnostic Imaging Services
NP Nurse practitioner
NPI National Provider Identifier
NPP Nonphysician practitioner
NQS National Quality Strategy
OACT CMS's Office of the Actuary
OBRA '89 Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239)
OBRA '90 Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508)
OES Occupational Employment Statistics
OMB Office of Management and Budget
OPPS Outpatient prospective payment system
OT Occupational therapy
PA Physician assistant
PAMA Protecting Access to Medicare Act of 2014 (Pub. L. 113-93)
PAMPA Patient Access and Medicare Protection Act (Pub. L. 114-115)
PC Professional component
PCIP Primary Care Incentive Payment
PE Practice expense
PE/HR Practice expense per hour
PEAC Practice Expense Advisory Committee
PECOS Provider Enrollment, Chain, and Ownership System
PFS Physician Fee Schedule
PLE Provider-led Entity
PLI Professional Liability Insurance
PMA Premarket approval
PMH-NP Psychiatric mental health nurse practitioner
PPM Provider-Performed Microscopy
PQRS Physician Quality Reporting System
PPIS Physician Practice Expense Information Survey
PPS Prospective Payment System
PT Physical therapy
PT Proficiency Testing
PT/INR Prothrombin Time/International Normalized Ratio
PY Performance year
QA Quality Assessment
QC Quality Control
QCDR Qualified clinical data registry
QRUR Quality and Resources Use Report
RBRVS Resource-based relative value scale
RFA Regulatory Flexibility Act
RHC Rural health clinic
RIA Regulatory impact analysis
RUC American Medical Association/Specialty Society Relative Value
Scale Update Committee
RUCA Rural Urban Commuting Area
RVU Relative value unit
SBA Small Business Administration
SGR Sustainable growth rate
SIM State Innovation Model
SLP Speech-language pathology
SMS Socioeconomic Monitoring System
SNF Skilled nursing facility
TAP Technical Advisory Panel
TC Technical component
TIN Tax identification number
TCM Transitional Care Management
UAF Update adjustment factor
UPIN Unique Physician Identification Number
USPSTF United States Preventive Services Task Force
VBP Value-based purchasing
VM Value-Based Payment Modifier
Addenda Available Only Through the Internet on the CMS Web Site
The PFS Addenda along with other supporting documents and tables
referenced in this final rule are available on the CMS Web site at
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. Click on the
link on the left side of the screen titled, ``PFS Federal Regulations
Notices'' for a chronological list of PFS Federal Register and other
related documents. For the CY 2018 PFS Final Rule, refer to item CMS-
1676-F. Readers with questions related to accessing any of the Addenda
or other supporting documents referenced in this final rule and posted
on the CMS Web site identified above should contact Jessica Bruton at
(410) 786-5991.
CPT (Current Procedural Terminology) Copyright Notice
Throughout this final rule, we use CPT codes and descriptions to
refer to a variety of services. We note that CPT codes and descriptions
are copyright 2016 American Medical Association. All Rights Reserved.
CPT is a registered trademark of the American Medical Association
(AMA). Applicable Federal Acquisition Regulations (FAR) and Defense
Federal Acquisition Regulations (DFAR) apply.
[[Page 52978]]
I. Executive Summary
A. Purpose
This final rule makes payment and policy changes under the Medicare
Physician Fee Schedule (PFS) and implements required statutory changes
under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)
(Pub. L. 114-10), Achieving a Better Life Experience Act of 2014 (ABLE)
(Pub. L. 113-295), Protecting Access to Medicare Act of 2014 (PAMA)
(Pub. L. 113-93), and the Consolidated Appropriations Act of 2016 (Pub.
L. 114-113). This final rule also makes changes to payment policy and
other related policies for Medicare Part B, Part D, and Medicare
Advantage.
1. Summary of the Major Provisions
Section 1848 of the Social Security Act (the Act) requires us to
establish payments under the PFS based on national uniform relative
value units (RVUs) that account for the relative resources used in
furnishing a service. The statute requires that RVUs be established for
three categories of resources: Work, practice expense (PE); and
malpractice (MP) expense; and, that we establish by regulation each
year's payment amounts for all physicians' services paid under the PFS,
incorporating geographic adjustments to reflect the variations in the
costs of furnishing services in different geographic areas. In this
major final rule, we establish RVUs for CY 2018 for the PFS, and other
Medicare Part B payment policies, to ensure that our payment systems
are updated to reflect changes in medical practice and the relative
value of services, as well as changes in the statute. In addition, this
final rule includes discussions and finalized policies regarding:
Potentially Misvalued Codes.
Telehealth Services.
Establishing Values for New, Revised, and Misvalued Codes.
Establishing Payment Rates under the PFS for Nonexcepted
Items and Services Furnished by Nonexcepted Off-Campus Provider-Based
Departments of a Hospital.
Evaluation & Management (E/M) Guidelines and Care
Management Services.
Care Coordination Services and Payment for Rural Health
Clinics (RHCs) and Federally Qualified Health Centers (FQHCs).
Part B Drug Payment: Infusion Drugs Furnished Through an
Item of Durable Medical Equipment (DME).
Solicitation of Public Comments on Initial Data Collection
and Reporting Periods for Clinical Laboratory Fee Schedule.
Payment for Biosimilar Biological Products under Section
1847A of the Act.
Appropriate Use Criteria for Advanced Diagnostic Imaging
Services.
PQRS Criteria for Satisfactory Reporting for Individual
EPs and Group Practices for the 2018 PQRS Payment Adjustment.
Clinical Quality Measurement for Eligible Professionals
Participating in the Electronic Health Record (EHR) Incentive Program
for 2016.
Medicare Shared Savings Program.
Value-Based Payment Modifier and the Physician Feedback
Program.
MACRA Patient Relationship Categories and Codes.
Changes to the Medicare Diabetes Prevention Program (MDPP)
Expanded Model.
Physician Self Referral Law: Annual Update to the List of
CPT/HCPCS Codes.
Therapy Caps.
2. Summary of Costs and Benefits
The statute requires that annual adjustments to PFS RVUs may not
cause annual estimated expenditures to differ by more than $20 million
from what they would have been had the adjustments not been made. If
adjustments to RVUs would cause expenditures to change by more than $20
million, we must make adjustments to preserve budget neutrality. These
adjustments can affect the distribution of Medicare expenditures across
specialties. We have determined that this major final rule is
economically significant. For a detailed discussion of the economic
impacts, see section V. of this final rule.
II. Provisions of the Final Rule, and Analysis of and Responses to
Public Comments for PFS
A. Background
Since January 1, 1992, Medicare has paid for physicians' services
under section 1848 of the Act, ``Payment for Physicians' Services.''
The PFS relies on national relative values that are established for
work, PE, and MP, which are adjusted for geographic cost variations.
These values are multiplied by a conversion factor (CF) to convert the
RVUs into payment rates. The concepts and methodology underlying the
PFS were enacted as part of the Omnibus Budget Reconciliation Act of
1989 (Pub. L. 101-239, enacted on December 19, 1989) (OBRA '89), and
the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508, enacted
on November 5, 1990) (OBRA '90). The final rule published on November
25, 1991 (56 FR 59502) set forth the first fee schedule used for
payment for physicians' services.
We note that throughout this major final rule, unless otherwise
noted, the term ``practitioner'' is used to describe both physicians
and nonphysician practitioners (NPPs) who are permitted to bill
Medicare under the PFS for services furnished to Medicare
beneficiaries.
1. Development of the Relative Values
a. Work RVUs
The work RVUs established for the initial fee schedule, which was
implemented on January 1, 1992, were developed with extensive input
from the physician community. A research team at the Harvard School of
Public Health developed the original work RVUs for most codes under a
cooperative agreement with the Department of Health and Human Services
(HHS). In constructing the code-specific vignettes used in determining
the original physician work RVUs, Harvard worked with panels of
experts, both inside and outside the federal government, and obtained
input from numerous physician specialty groups.
As specified in section 1848(c)(1)(A) of the Act, the work
component of physicians' services means the portion of the resources
used in furnishing the service that reflects physician time and
intensity. We establish work RVUs for new, revised and potentially
misvalued codes based on our review of information that generally
includes, but is not limited to, recommendations received from the
American Medical Association/Specialty Society Relative Value Scale
Update Committee (RUC), the Health Care Professionals Advisory
Committee (HCPAC), the Medicare Payment Advisory Commission (MedPAC),
and other public commenters; medical literature and comparative
databases; as well as a comparison of the work for other codes within
the Medicare PFS, and consultation with other physicians and health
care professionals within CMS and the federal government. We also
assess the methodology and data used to develop the recommendations
submitted to us by the RUC and other public commenters, and the
rationale for their recommendations. In the CY 2011 PFS final rule with
comment period (75 FR 73328 through 73329), we discussed a variety of
methodologies and approaches used to develop work RVUs, including
survey data, building blocks, crosswalk to key reference or
[[Page 52979]]
similar codes, and magnitude estimation. More information on these
issues is available in that rule.
b. Practice Expense RVUs
Initially, only the work RVUs were resource-based, and the PE and
MP RVUs were based on average allowable charges. Section 121 of the
Social Security Act Amendments of 1994 (Pub. L. 103-432, enacted on
October 31, 1994), amended section 1848(c)(2)(C)(ii) of the Act and
required us to develop resource-based PE RVUs for each physicians'
service beginning in 1998. We were required to consider general
categories of expenses (such as office rent and wages of personnel, but
excluding malpractice expenses) comprising PEs. The PE RVUs continue to
represent the portion of these resources involved in furnishing PFS
services.
Originally, the resource-based method was to be used beginning in
1998, but section 4505(a) of the Balanced Budget Act of 1997 (Pub. L.
105-33, enacted on August 5, 1997) (BBA) delayed implementation of the
resource-based PE RVU system until January 1, 1999. In addition,
section 4505(b) of the BBA provided for a 4-year transition period from
the charge-based PE RVUs to the resource-based PE RVUs.
We established the resource-based PE RVUs for each physicians'
service in a final rule, published on November 2, 1998 (63 FR 58814),
effective for services furnished in CY 1999. Based on the requirement
to transition to a resource-based system for PE over a 4-year period,
payment rates were not fully based upon resource-based PE RVUs until CY
2002. This resource-based system was based on two significant sources
of actual PE data: The Clinical Practice Expert Panel (CPEP) data; and
the AMA's Socioeconomic Monitoring System (SMS) data. These data
sources are described in greater detail in the CY 2012 final rule with
comment period (76 FR 73033).
Separate PE RVUs are established for services furnished in facility
settings, such as a hospital outpatient department (HOPD) or an
ambulatory surgical center (ASC), and in nonfacility settings, such as
a physician's office. The nonfacility RVUs reflect all of the direct
and indirect PEs involved in furnishing a service described by a
particular HCPCS code. The difference, if any, in these PE RVUs
generally results in a higher payment in the nonfacility setting
because in the facility settings some costs are borne by the facility.
Medicare's payment to the facility (such as the outpatient prospective
payment system (OPPS) payment to the HOPD) would reflect costs
typically incurred by the facility. Thus, payment associated with those
facility resources is not made under the PFS.
Section 212 of the Balanced Budget Refinement Act of 1999 (Pub. L.
106-113, enacted on November 29, 1999) (BBRA) directed the Secretary of
Health and Human Services (the Secretary) to establish a process under
which we accept and use, to the maximum extent practicable and
consistent with sound data practices, data collected or developed by
entities and organizations to supplement the data we normally collect
in determining the PE component. On May 3, 2000, we published the
interim final rule (65 FR 25664) that set forth the criteria for the
submission of these supplemental PE survey data. The criteria were
modified in response to comments received, and published in the Federal
Register (65 FR 65376) as part of a November 1, 2000 final rule. The
PFS final rules published in 2001 and 2003, respectively, (66 FR 55246
and 68 FR 63196) extended the period during which we would accept these
supplemental data through March 1, 2005.
In the CY 2007 PFS final rule with comment period (71 FR 69624), we
revised the methodology for calculating direct PE RVUs from the top-
down to the bottom-up methodology beginning in CY 2007. We adopted a 4-
year transition to the new PE RVUs. This transition was completed for
CY 2010. In the CY 2010 PFS final rule with comment period, we updated
the practice expense per hour (PE/HR) data that are used in the
calculation of PE RVUs for most specialties (74 FR 61749). In CY 2010,
we began a 4-year transition to the new PE RVUs using the updated PE/HR
data, which was completed for CY 2013.
c. Malpractice RVUs
Section 4505(f) of the BBA amended section 1848(c) of the Act to
require that we implement resource-based MP RVUs for services furnished
on or after CY 2000. The resource-based MP RVUs were implemented in the
PFS final rule with comment period published November 2, 1999 (64 FR
59380). The MP RVUs are based on commercial and physician-owned
insurers' malpractice insurance premium data from all the states, the
District of Columbia, and Puerto Rico. For more information on MP RVUs,
see section II.C. of this final rule.
d. Refinements to the RVUs
Section 1848(c)(2)(B)(i) of the Act requires that we review RVUs no
less often than every 5 years. Prior to CY 2013, we conducted periodic
reviews of work RVUs and PE RVUs independently. We completed 5-year
reviews of work RVUs that were effective for calendar years 1997, 2002,
2007, and 2012.
Although refinements to the direct PE inputs initially relied
heavily on input from the RUC Practice Expense Advisory Committee
(PEAC), the shifts to the bottom-up PE methodology in CY 2007 and to
the use of the updated PE/HR data in CY 2010 have resulted in
significant refinements to the PE RVUs in recent years.
In the CY 2012 PFS final rule with comment period (76 FR 73057), we
finalized a proposal to consolidate reviews of work and PE RVUs under
section 1848(c)(2)(B) of the Act and reviews of potentially misvalued
codes under section 1848(c)(2)(K) of the Act into one annual process.
In addition to the 5-year reviews, beginning for CY 2009, CMS and
the RUC have identified and reviewed a number of potentially misvalued
codes on an annual basis based on various identification screens. This
annual review of work and PE RVUs for potentially misvalued codes was
supplemented by the amendments to section 1848 of the Act, as enacted
by section 3134 of the Affordable Care Act, that require the agency to
periodically identify, review and adjust values for potentially
misvalued codes.
e. Application of Budget Neutrality to Adjustments of RVUs
As described in section V.C. of this final rule, in accordance with
section 1848(c)(2)(B)(ii)(II) of the Act, if revisions to the RVUs
cause expenditures for the year to change by more than $20 million, we
make adjustments to ensure that expenditures do not increase or
decrease by more than $20 million.
2. Calculation of Payments Based on RVUs
To calculate the payment for each service, the components of the
fee schedule (work, PE, and MP RVUs) are adjusted by geographic
practice cost indices (GPCIs) to reflect the variations in the costs of
furnishing the services. The GPCIs reflect the relative costs of work,
PE, and MP in an area compared to the national average costs for each
component.
RVUs are converted to dollar amounts through the application of a
CF, which
[[Page 52980]]
is calculated based on a statutory formula by CMS's Office of the
Actuary (OACT). The formula for calculating the Medicare PFS payment
amount for a given service and fee schedule area can be expressed as:
Payment = [(RVU work x GPCI work) + (RVU PE x GPCI PE) + (RVU MP x GPCI
MP)] x CF
3. Separate Fee Schedule Methodology for Anesthesia Services
Section 1848(b)(2)(B) of the Act specifies that the fee schedule
amounts for anesthesia services are to be based on a uniform relative
value guide, with appropriate adjustment of an anesthesia CF, in a
manner to ensure that fee schedule amounts for anesthesia services are
consistent with those for other services of comparable value.
Therefore, there is a separate fee schedule methodology for anesthesia
services. Specifically, we establish a separate CF for anesthesia
services and we utilize the uniform relative value guide, or base
units, as well as time units, to calculate the fee schedule amounts for
anesthesia services. Since anesthesia services are not valued using
RVUs, a separate methodology for locality adjustments is also
necessary. This involves an adjustment to the national anesthesia CF
for each payment locality.
B. Determination of Practice Expense (PE) Relative Value Units (RVUs)
1. Overview
Practice expense (PE) is the portion of the resources used in
furnishing a service that reflects the general categories of physician
and practitioner expenses, such as office rent and personnel wages, but
excluding malpractice expenses, as specified in section 1848(c)(1)(B)
of the Act. As required by section 1848(c)(2)(C)(ii) of the Act, we use
a resource-based system for determining PE RVUs for each physicians'
service. We develop PE RVUs by considering the direct and indirect
practice resources involved in furnishing each service. Direct expense
categories include clinical labor, medical supplies, and medical
equipment. Indirect expenses include administrative labor, office
expense, and all other expenses. The sections that follow provide more
detailed information about the methodology for translating the
resources involved in furnishing each service into service-specific PE
RVUs. We refer readers to the CY 2010 PFS final rule with comment
period (74 FR 61743 through 61748) for a more detailed explanation of
the PE methodology.
2. Practice Expense Methodology
a. Direct Practice Expense
We determine the direct PE for a specific service by adding the
costs of the direct resources (that is, the clinical staff, medical
supplies, and medical equipment) typically involved with furnishing
that service. The costs of the resources are calculated using the
refined direct PE inputs assigned to each CPT code in our PE database,
which are generally based on our review of recommendations received
from the RUC and those provided in response to public comment periods.
For a detailed explanation of the direct PE methodology, including
examples, we refer readers to the 5 Year Review of Work Relative Value
Units under the PFS and Proposed Changes to the Practice Expense
Methodology proposed notice (71 FR 37242) and the CY 2007 PFS final
rule with comment period (71 FR 69629).
b. Indirect Practice Expense per Hour Data
We use survey data on indirect PEs incurred per hour worked in
developing the indirect portion of the PE RVUs. Prior to CY 2010, we
primarily used the PE/HR by specialty that was obtained from the AMA's
SMS. The AMA administered a new survey in CY 2007 and CY 2008, the
Physician Practice Expense Information Survey (PPIS). The PPIS is a
multispecialty, nationally representative, PE survey of both physicians
and NPPs paid under the PFS using a survey instrument and methods
highly consistent with those used for the SMS and the supplemental
surveys. The PPIS gathered information from 3,656 respondents across 51
physician specialty and health care professional groups. We believe the
PPIS is the most comprehensive source of PE survey information
available. We used the PPIS data to update the PE/HR data for the CY
2010 PFS for almost all of the Medicare-recognized specialties that
participated in the survey.
When we began using the PPIS data in CY 2010, we did not change the
PE RVU methodology itself or the manner in which the PE/HR data are
used in that methodology. We only updated the PE/HR data based on the
new survey. Furthermore, as we explained in the CY 2010 PFS final rule
with comment period (74 FR 61751), because of the magnitude of payment
reductions for some specialties resulting from the use of the PPIS
data, we transitioned its use over a 4-year period from the previous PE
RVUs to the PE RVUs developed using the new PPIS data. As provided in
the CY 2010 PFS final rule with comment period (74 FR 61751), the
transition to the PPIS data was complete for CY 2013. Therefore, PE
RVUs from CY 2013 forward are developed based entirely on the PPIS
data, except as noted in this section.
Section 1848(c)(2)(H)(i) of the Act requires us to use the medical
oncology supplemental survey data submitted in 2003 for oncology drug
administration services. Therefore, the PE/HR for medical oncology,
hematology, and hematology/oncology reflects the continued use of these
supplemental survey data.
Supplemental survey data on independent labs from the College of
American Pathologists were implemented for payments beginning in CY
2005. Supplemental survey data from the National Coalition of Quality
Diagnostic Imaging Services (NCQDIS), representing independent
diagnostic testing facilities (IDTFs), were blended with supplementary
survey data from the American College of Radiology (ACR) and
implemented for payments beginning in CY 2007. Neither IDTFs, nor
independent labs, participated in the PPIS. Therefore, we continue to
use the PE/HR that was developed from their supplemental survey data.
Consistent with our past practice, the previous indirect PE/HR values
from the supplemental surveys for these specialties were updated to CY
2006 using the Medicare Economic Index (MEI) to put them on a
comparable basis with the PPIS data.
We also do not use the PPIS data for reproductive endocrinology and
spine surgery since these specialties currently are not separately
recognized by Medicare, nor do we have a method to blend the PPIS data
with Medicare-recognized specialty data.
Previously, we established PE/HR values for various specialties
without SMS or supplemental survey data by crosswalking them to other
similar specialties to estimate a proxy PE/HR. For specialties that
were part of the PPIS for which we previously used a crosswalked PE/HR,
we instead used the PPIS-based PE/HR. We use crosswalks for specialties
that did not participate in the PPIS. These crosswalks have been
generally established through notice and comment rulemaking and are
available in the file called ``CY 2018 PFS Final Rule PE/HR'' on the
CMS Web site under downloads for the CY 2018 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
Comment: Several commenters recommended that it was time to
consider a new nationwide all specialty
[[Page 52981]]
PE/HR survey, given the amount of time that has passed since the last
survey was conducted. The commenters stated that the practice of
medicine has significantly and substantially evolved in the past decade
and that many specialties have had extensive changes in physician
employment models during that time. The commenters stated that
continued use of the outdated PPIS survey leads to an inappropriate and
inaccurate distortion of the PE RVUs for current practice.
Response: We have previously identified several concerns regarding
the underlying data used in determining PE RVUs in the CY 2014 PFS
final rule (78 FR 74246 through 74247). Even when we first incorporated
the survey data into the PE methodology beginning in CY 1999 (63 FR
58814), many commenters expressed serious concerns over the accuracy of
this or other PE surveys as a way of gathering data on PE inputs from
the diversity of providers paid under the PFS. However, we currently
lack another source of comprehensive data regarding PE costs, and as a
result, we continue to believe that the PPIS survey data is the best
data currently available. We continue to seek the best broad-based,
auditable, routinely-updated source of information regarding PE costs.
c. Allocation of PE to Services
To establish PE RVUs for specific services, it is necessary to
establish the direct and indirect PE associated with each service.
(1) Direct Costs
The relative relationship between the direct cost portions of the
PE RVUs for any two services is determined by the relative relationship
between the sum of the direct cost resources (that is, the clinical
staff, medical supplies, and medical equipment) typically involved with
furnishing each of the services. The costs of these resources are
calculated from the refined direct PE inputs in our PE database. For
example, if one service has a direct cost sum of $400 from our PE
database and another service has a direct cost sum of $200, the direct
portion of the PE RVUs of the first service would be twice as much as
the direct portion of the PE RVUs for the second service.
(2) Indirect Costs
We allocate the indirect costs to the code level on the basis of
the direct costs specifically associated with a code and the greater of
either the clinical labor costs or the work RVUs. We also incorporate
the survey data described earlier in the PE/HR discussion (see section
II.B.2.b of this final rule). The general approach to developing the
indirect portion of the PE RVUs is as follows:
For a given service, we use the direct portion of the PE
RVUs calculated as previously described and the average percentage that
direct costs represent of total costs (based on survey data) across the
specialties that furnish the service to determine an initial indirect
allocator. That is, the initial indirect allocator is calculated so
that the direct costs equal the average percentage of direct costs of
those specialties furnishing the service. For example, if the direct
portion of the PE RVUs for a given service is 2.00 and direct costs, on
average, represent 25 percent of total costs for the specialties that
furnish the service, the initial indirect allocator would be calculated
so that it equals 75 percent of the total PE RVUs. Thus, in this
example, the initial indirect allocator would equal 6.00, resulting in
a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75
percent of 8.00).
Next, we add the greater of the work RVUs or clinical
labor portion of the direct portion of the PE RVUs to this initial
indirect allocator. In our example, if this service had a work RVU of
4.00 and the clinical labor portion of the direct PE RVU was 1.50, we
would add 4.00 (since the 4.00 work RVUs are greater than the 1.50
clinical labor portion) to the initial indirect allocator of 6.00 to
get an indirect allocator of 10.00. In the absence of any further use
of the survey data, the relative relationship between the indirect cost
portions of the PE RVUs for any two services would be determined by the
relative relationship between these indirect cost allocators. For
example, if one service had an indirect cost allocator of 10.00 and
another service had an indirect cost allocator of 5.00, the indirect
portion of the PE RVUs of the first service would be twice as great as
the indirect portion of the PE RVUs for the second service.
Next, we incorporated the specialty-specific indirect PE/
HR data into the calculation. In our example, if, based on the survey
data, the average indirect cost of the specialties furnishing the first
service with an allocator of 10.00 was half of the average indirect
cost of the specialties furnishing the second service with an indirect
allocator of 5.00, the indirect portion of the PE RVUs of the first
service would be equal to that of the second service.
(3) Facility and Nonfacility Costs
For procedures that can be furnished in a physician's office, as
well as in a facility setting, where Medicare makes a separate payment
to the facility for its costs in furnishing a service, we establish two
PE RVUs: Facility and nonfacility. The methodology for calculating PE
RVUs is the same for both the facility and nonfacility RVUs, but is
applied independently to yield two separate PE RVUs. In calculating the
PE RVUs for services furnished in a facility, we do not include
resources that would generally not be provided by physicians when
furnishing the service. For this reason, the facility PE RVUs are
generally lower than the nonfacility PE RVUs.
Comment: One commenter requested that CMS develop nonfacility PE
RVUs for CPT code 31255 (Nasal/sinus endoscopy, surgical; with
ethmoidectomy, total (anterior and posterior)), stating that this would
be consistent with the migration of many sinus surgery procedures to
the office setting. The commenter indicated that the availability of
new technology has transformed these services to become minimally
invasive, and as a result, they can be safely and effectively performed
in the office setting for many patients.
Response: We appreciate the information provided by the commenter.
However, we note that CPT code 31255 was reviewed by the RUC for the
current CY 2018 rule cycle, and the RUC did not recommend any direct PE
inputs for this code in the nonfacility setting. We welcome an ongoing
dialogue with stakeholders regarding the direct PE inputs for this
code, which we will take under consideration for future rulemaking. We
also note that pricing in a particular setting does not constitute a
coverage determination.
(4) Services With Technical Components and Professional Components
Diagnostic services are generally comprised of two components: A
professional component (PC) and a technical component (TC). The PC and
TC may be furnished independently or by different providers, or they
may be furnished together as a global service. When services have
separately billable PC and TC components, the payment for the global
service equals the sum of the payment for the TC and PC. To achieve
this, we use a weighted average of the ratio of indirect to direct
costs across all the specialties that furnish the global service, TCs,
and PCs; that is, we apply the same weighted average indirect
percentage factor to allocate indirect expenses to the global service,
PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum
to the global.)
[[Page 52982]]
(5) PE RVU Methodology
For a more detailed description of the PE RVU methodology, we refer
readers to the CY 2010 PFS final rule with comment period (74 FR 61745
through 61746). We also direct interested readers to the file called
``Calculation of PE RVUs under Methodology for Selected Codes'' which
is available on our Web site under downloads for the CY 2018 PFS final
rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. This file
contains a table that illustrates the calculation of PE RVUs as
described in this final rule for individual codes.
(a) Setup File
First, we create a setup file for the PE methodology. The setup
file contains the direct cost inputs, the utilization for each
procedure code at the specialty and facility/nonfacility place of
service level, and the specialty-specific PE/HR data calculated from
the surveys.
(b) Calculate the Direct Cost PE RVUs
Sum the costs of each direct input.
Step 1: Sum the direct costs of the inputs for each service.
Step 2: Calculate the aggregate pool of direct PE costs for the
current year. We set the aggregate pool of PE costs equal to the
product of the ratio of the current aggregate PE RVUs to current
aggregate work RVUs and the proposed aggregate work RVUs.
Step 3: Calculate the aggregate pool of direct PE costs for use in
ratesetting. This is the product of the aggregate direct costs for all
services from Step 1 and the utilization data for that service.
Step 4: Using the results of Step 2 and Step 3, use the CF to
calculate a direct PE scaling adjustment to ensure that the aggregate
pool of direct PE costs calculated in Step 3 does not vary from the
aggregate pool of direct PE costs for the current year. Apply the
scaling adjustment to the direct costs for each service (as calculated
in Step 1).
Step 5: Convert the results of Step 4 to a RVU scale for each
service. To do this, divide the results of Step 4 by the CF. Note that
the actual value of the CF used in this calculation does not influence
the final direct cost PE RVUs as long as the same CF is used in Step 4
and Step 5. Different CFs would result in different direct PE scaling
adjustments, but this has no effect on the final direct cost PE RVUs
since changes in the CFs and changes in the associated direct scaling
adjustments offset one another.
(c) Create the Indirect Cost PE RVUs
Create indirect allocators.
Step 6: Based on the survey data, calculate direct and indirect PE
percentages for each physician specialty.
Step 7: Calculate direct and indirect PE percentages at the service
level by taking a weighted average of the results of Step 6 for the
specialties that furnish the service. Note that for services with TCs
and PCs, the direct and indirect percentages for a given service do not
vary by the PC, TC, and global service.
We generally use an average of the 3 most recent years of available
Medicare claims data to determine the specialty mix assigned to each
code. Prior to implementing that policy, we used the most recent year
of available claims data to determine the specialty mix assigned to
each code.
Under either of these approaches, codes with low Medicare service
volume require special attention since billing or enrollment
irregularities for a given year can result in significant changes in
specialty mix assignment. Prior to adopting the 3-year average of data,
for low-volume services (fewer than 100 Medicare allowed services), we
assigned the values associated with the specialty that most frequently
reported the service in the most recent claims data (dominant
specialty). For some time, stakeholders, including the RUC, have
requested that we use a recommended ``expected'' specialty for all low
volume services instead of the information contained in the claims
data. Currently, in the development of PE RVUs we use ``expected
specialty'' overrides for only several dozen services based on several
code-specific policies we established in prior rulemaking. As we stated
in the CY 2016 final rule with comment period (80 FR 70894), we hoped
that the 3-year average would mitigate the need to use dominant or
expected specialty instead of the specialty identified using claims
data. Because we incorporated CY 2015 claims data for use in the CY
2017 proposed rates, we believe that the finalized PE RVUs associated
with the CY 2017 PFS final rule provided a first opportunity to
determine whether service-level overrides of claims data are necessary.
Although we believe that the use of the 3-year average of claims
data to determine specialty mix has led to an improvement in the
stability of PE and MP RVUs from year to year, after reviewing the RVUs
for low volume services, we continue to see possible distortions and
wide variability from year to year in PE and MP RVUs for low volume
services. Several stakeholders have suggested that CMS implement
service-level overrides based on the expected specialty in order to
determine the specialty mix for these low volume procedures. The RUC
previously supplied us with a list of nearly 2,000 lower volume codes
and their suggested specialty overrides. After reviewing the finalized
PE RVUs for the CY 2017 PFS final rule, we agree that the use of
service-level overrides for low volume services would help mitigate
annual fluctuations and provide greater stability in the valuation of
these services. While the use of the 3-year average of claims data to
determine specialty mix has helped to mitigate some of the year to year
variability for low volume services, it has not fully mitigated what
appear to be anomalies for many of these lower volume codes.
Therefore, we proposed to use the most recent year of claims data
to determine which codes are low volume for the coming year (those that
have fewer than 100 allowed services in the Medicare claims data). For
codes that fall into this category, instead of assigning specialty mix
based on the specialties of the practitioners reporting the services in
the claims data, we proposed to instead use the expected specialty that
we identify on a list. For CY 2018, we proposed to use a list that was
developed based on our medical review of the list most recently
recommended by the RUC, in addition to our own proposed expected
specialty for certain other low-volume codes for which we have
historically used expected specialty assignments. We would display this
list as part of the annual set of data files we make available as part
of notice and comment rulemaking. We proposed to consider
recommendations from the RUC and other stakeholders on changes to this
list on an annual basis.
We also proposed to apply these service-level overrides for both PE
and MP, rather than one or the other category. We believe that this
would simplify the implementation of service-level overrides for PE and
MP, and would also address stakeholder concerns about the year-to-year
variability for low volume services. We solicited public comment on the
proposal to use service-level overrides to determine the specialty mix
for low volume procedures, as well as on the proposed list of expected
specialty overrides itself, which is largely based on the
recommendations submitted by the RUC last year. The proposed list of
expected specialty assignments for individual low volume services is
available on our Web site under downloads for the CY 2018 PFS proposed
rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-
[[Page 52983]]
Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. Services
for which the specialty is automatically assigned based on previously
finalized policies under our established methodology (for example,
``always therapy'' services) would be unaffected by this proposal.
The following is a summary of the public comments received on our
proposal to use service-level overrides to determine the specialty mix
for low volume procedures and our responses:
Comment: Many commenters supported the use of the expected
specialty assignments and urged CMS to finalize the proposal.
Commenters stated that the proposal was consistent with a longstanding
RUC recommendation and the use of the expected specialty assignments
would help mitigate some of the year to year variability for low volume
services. Commenters supported the creation of a list of these service-
level overrides and its maintenance on an annual basis, with several
commenters stating that the RUC should review updated claims data each
year to determine if any new codes fall below 100 claims and submit an
expected specialty recommendation for these additional codes.
Response: We appreciate the comments in support of the proposal. As
we stated in the proposed rule, we will consider recommendations from
the RUC and other stakeholders on changes to the list of expected
specialty assignments on an annual basis.
Comment: Several commenters made specific recommendations about the
proposed list of expected specialty assignments for individual low
volume services. One commenter recommended that the following CPT codes
should be added to the list of expected specialty assignments:
Cardiology: 33477; Cardiac surgery: 33238, 33514, 33548, 33951, 33953,
33955, 33957, 33958, 33959, 33962, 33963, 33964, 33965, 33969, 33973,
33985, 33987, 33988, 33989, 33991, 35271; General Surgery: 35251,
43325; Thoracic Surgery: 32672, 33025, 33215, 43135. The same commenter
recommended the following changes to the indicated codes on the low
volume override list:
CPT codes 33363 and 33364: The commenter recommended
changing the override specialty from cardiology to cardiac surgery.
CPT codes 33516, 33976 and 35812: The commenter
recommended changing the override specialty from thoracic surgery to
cardiac surgery.
CPT codes 35311 and 35526: The commenter recommended
changing the override specialty from vascular surgery to cardiac
surgery.
CPT codes 38382, 43108, 43118, 43123, 43360, 43405 and
43425: The commenter recommended changing the override specialty from
general surgery to thoracic surgery.
In addition, a different commenter recommended changing the
proposed expected specialty for CPT code 43754 from gastroenterology to
emergency medicine.
Response: We appreciate the submission of specific recommendations
to the proposed list of expected specialty assignments. These
recommendations from the commenter included newer information about the
typical practice of these CPT codes than what we possessed when
initially proposing the low volume services list, which was based, in
part, upon a review that took place in CY 2016. After reviewing the
recommendations provided by the commenters, and in light of the
additional information supplied by the commenter about these codes, we
are finalizing the addition of these updated recommendations to the
list.
Comment: Several commenters expressed concern regarding the
treatment of existing codes with no Medicare volume (as distinct from
low volume) reported for any given year. Under the methodology used in
the proposed rule, these codes with no utilization data received the
average risk factor for all physician specialties rather than the
expected specialty assignments on the list of service-level overrides.
The commenters recommended that the proposed list of expected specialty
overrides be utilized for both low volume and no volume codes.
Response: We agree with the commenters that the RVUs for services
with no Medicare volume should be calculated in a manner that is
consistent with services with low Medicare volume because our proposal
was for fewer than 100 allowed services, and no-volume services would
fit within that standard. Therefore, we are finalizing the
recommendation from the commenters to use the proposed list of expected
specialty overrides for both low volume and no volume codes.
Comment: A commenter agreed with the CMS proposal that there would
no longer be a need to apply service-level MP RVU crosswalks for new or
revised codes in order to assign a specialty-mix risk factor. The
commenter stated that CMS would be able to derive the specialty mix
assumption in the first year for a new or revised code from the
specialty mix used for purposes of ratesetting. The commenter indicated
their support for this change to calculating MP RVUs for new or revised
codes.
Response: We are finalizing our proposal to remove service-level MP
RVU crosswalks for new or revised codes, and we will instead derive the
specialty mix assumption for the first year for a new or revised code
from the specialty mix used for purposes of ratesetting.
Comment: One commenter supported the CMS proposal and requested the
use of the phrase ``Family Medicine'' for the list of expected
specialty assignments rather than the phrase ``Family Practice'', which
the commenter stated was a more outdated term.
Response: Regarding the requested update to the name assigned to a
specialty, we would direct the commenter to the standard process for
updating specialty designations. This change would have to be made to
the Medicare enrollment specialty and lies outside the scope of the
proposal.
After consideration of comments received, we are finalizing our
proposal to use service-level overrides to determine the specialty mix
for low volume procedures, with the modifications as discussed in this
section. Based on comments, we are also finalizing the use of service-
level overrides to determine the specialty mix for no volume
procedures. In addition, we are finalizing the proposed list of
expected specialty overrides with modifications. We are finalizing the
addition of certain CPT codes to the list and updated specialty
assignments for certain CPT codes.
Step 8: Calculate the service level allocators for the indirect PEs
based on the percentages calculated in Step 7. The indirect PEs are
allocated based on the three components: The direct PE RVUs; the
clinical labor PE RVUs; and the work RVUs.
For most services the indirect allocator is: Indirect PE percentage
* (direct PE RVUs/direct percentage) + work RVUs.
There are two situations where this formula is modified:
If the service is a global service (that is, a service
with global, professional, and technical components), then the indirect
PE allocator is: Indirect percentage (direct PE RVUs/direct percentage)
+ clinical labor PE RVUs + work RVUs.
If the clinical labor PE RVUs exceed the work RVUs (and
the service is not a global service), then the indirect allocator is:
Indirect PE percentage (direct PE RVUs/direct percentage) + clinical
labor PE RVUs.
(Note: For global services, the indirect PE allocator is based on
both the work
[[Page 52984]]
RVUs and the clinical labor PE RVUs. We do this to recognize that, for
the PC service, indirect PEs would be allocated using the work RVUs,
and for the TC service, indirect PEs would be allocated using the
direct PE RVUs and the clinical labor PE RVUs. This also allows the
global component RVUs to equal the sum of the PC and TC RVUs.)
For presentation purposes, in the examples in the download file
called ``Calculation of PE RVUs under Methodology for Selected Codes'',
the formulas were divided into two parts for each service.
The first part does not vary by service and is the
indirect percentage (direct PE RVUs/direct percentage).
The second part is either the work RVU, clinical labor PE
RVU, or both depending on whether the service is a global service and
whether the clinical PE RVUs exceed the work RVUs (as described earlier
in this step).
Apply a scaling adjustment to the indirect allocators.
Step 9: Calculate the current aggregate pool of indirect PE RVUs by
multiplying the result of step 8 by the average indirect PE percentage
from the survey data.
Step 10: Calculate an aggregate pool of indirect PE RVUs for all
PFS services by adding the product of the indirect PE allocators for a
service from Step 8 and the utilization data for that service.
Step 11: Using the results of Step 9 and Step 10, calculate an
indirect PE adjustment so that the aggregate indirect allocation does
not exceed the available aggregate indirect PE RVUs and apply it to
indirect allocators calculated in Step 8.
Calculate the indirect practice cost index.
Step 12: Using the results of Step 11, calculate aggregate pools of
specialty-specific adjusted indirect PE allocators for all PFS services
for a specialty by adding the product of the adjusted indirect PE
allocator for each service and the utilization data for that service.
Step 13: Using the specialty-specific indirect PE/HR data,
calculate specialty-specific aggregate pools of indirect PE for all PFS
services for that specialty by adding the product of the indirect PE/HR
for the specialty, the work time for the service, and the specialty's
utilization for the service across all services furnished by the
specialty.
Step 14: Using the results of Step 12 and Step 13, calculate the
specialty-specific indirect PE scaling factors.
Step 15: Using the results of Step 14, calculate an indirect
practice cost index at the specialty level by dividing each specialty-
specific indirect scaling factor by the average indirect scaling factor
for the entire PFS.
Step 16: Calculate the indirect practice cost index at the service
level to ensure the capture of all indirect costs. Calculate a weighted
average of the practice cost index values for the specialties that
furnish the service. (Note: For services with TCs and PCs, we calculate
the indirect practice cost index across the global service, PCs, and
TCs. Under this method, the indirect practice cost index for a given
service (for example, echocardiogram) does not vary by the PC, TC, and
global service.)
Step 17: Apply the service level indirect practice cost index
calculated in Step 16 to the service level adjusted indirect allocators
calculated in Step 11 to get the indirect PE RVUs.
(d) Calculate the Final PE RVUs
Step 18: Add the direct PE RVUs from Step 5 to the indirect PE RVUs
from Step 17 and apply the final PE budget neutrality (BN) adjustment.
The final PE BN adjustment is calculated by comparing the sum of steps
5 and 17 to the proposed aggregate work RVUs scaled by the ratio of
current aggregate PE and work RVUs. This adjustment ensures that all PE
RVUs in the PFS account for the fact that certain specialties are
excluded from the calculation of PE RVUs but included in maintaining
overall PFS budget neutrality. (See ``Specialties excluded from
ratesetting calculation'' later in this final rule.)
Step 19: Apply the phase-in of significant RVU reductions and its
associated adjustment. Section 1848(c)(7) of the Act specifies that for
services that are not new or revised codes, if the total RVUs for a
service for a year would otherwise be decreased by an estimated 20
percent or more as compared to the total RVUs for the previous year,
the applicable adjustments in work, PE, and MP RVUs shall be phased in
over a 2-year period. In implementing the phase-in, we consider a 19
percent reduction as the maximum 1-year reduction for any service not
described by a new or revised code. This approach limits the year one
reduction for the service to the maximum allowed amount (that is, 19
percent), and then phases in the remainder of the reduction. To comply
with section 1848(c)(7) of the Act, we adjust the PE RVUs to ensure
that the total RVUs for all services that are not new or revised codes
decrease by no more than 19 percent, and then apply a relativity
adjustment to ensure that the total pool of aggregate PE RVUs remains
relative to the pool of work and MP RVUs. For a more detailed
description of the methodology for the phase-in of significant RVU
changes, we refer readers to the CY 2016 PFS final rule with comment
period (80 FR 70927 through 70931).
Comment: One commenter stated that CMS should take a phased in
approach to avoid any beneficiary access issues presented by the
significant payment decreases caused by PE decreases for imaging
services. These decreases could affect the viability of many practices
providing these critical services as the new payment rates might create
economic hardships for continuation of these services. The commenter
stated that CMS should implement the RUC-recommended practice expenses
over a phased in period to reduce the financial impact of the PE
changes, particularly for codes with a proposed decrease of more than
10 percent.
Response: We agree with the commenter that there is a need to
ensure access to patient care and mitigate the potential for economic
hardship on the part of providers facing decreases in the valuation of
services. We note in response to the commenter that section 1848(c)(7)
of the Act already stipulates 19 percent as the maximum 1-year
reduction for any service not described by a new or revised code. This
phase-in methodology has been in use for PFS ratesetting since CY 2016.
(e) Setup File Information
Specialties excluded from ratesetting calculation: For the
purposes of calculating the PE RVUs, we exclude certain specialties,
such as certain NPPs paid at a percentage of the PFS and low-volume
specialties, from the calculation. These specialties are included for
the purposes of calculating the BN adjustment. They are displayed in
Table 1.
Table 1--Specialties Excluded From Ratesetting Calculation
------------------------------------------------------------------------
Specialty code Specialty description
------------------------------------------------------------------------
49........................... Ambulatory surgical center.
50........................... Nurse practitioner.
[[Page 52985]]
51........................... Medical supply company with certified
orthotist.
52........................... Medical supply company with certified
prosthetist.
53........................... Medical supply company with certified
prosthetist[dash]orthotist.
54........................... Medical supply company not included in
51, 52, or 53.
55........................... Individual certified orthotist.
56........................... Individual certified prosthetist.
57........................... Individual certified
prosthetist[dash]orthotist.
58........................... Medical supply company with registered
pharmacist.
59........................... Ambulance service supplier, e.g., private
ambulance companies, funeral homes, etc.
60........................... Public health or welfare agencies.
61........................... Voluntary health or charitable agencies.
73........................... Mass immunization roster biller.
74........................... Radiation therapy centers.
87........................... All other suppliers (e.g., drug and
department stores).
88........................... Unknown supplier/provider specialty.
89........................... Certified clinical nurse specialist.
96........................... Optician.
97........................... Physician assistant.
A0........................... Hospital.
A1........................... SNF.
A2........................... Intermediate care nursing facility.
A3........................... Nursing facility, other.
A4........................... HHA.
A5........................... Pharmacy.
A6........................... Medical supply company with respiratory
therapist.
A7........................... Department store.
B2........................... Pedorthic personnel.
B3........................... Medical supply company with pedorthic
personnel.
------------------------------------------------------------------------
Crosswalk certain low volume physician specialties:
Crosswalk the utilization of certain specialties with relatively low
PFS utilization to the associated specialties.
Physical therapy utilization: Crosswalk the utilization
associated with all physical therapy services to the specialty of
physical therapy.
Identify professional and technical services not
identified under the usual TC and 26 modifiers: Flag the services that
are PC and TC services but do not use TC and 26 modifiers (for example,
electrocardiograms). This flag associates the PC and TC with the
associated global code for use in creating the indirect PE RVUs. For
example, the professional service, CPT code 93010 (Electrocardiogram,
routine ECG with at least 12 leads; interpretation and report only), is
associated with the global service, CPT code 93000 (Electrocardiogram,
routine ECG with at least 12 leads; with interpretation and report).
Payment modifiers: Payment modifiers are accounted for in
the creation of the file consistent with current payment policy as
implemented in claims processing. For example, services billed with the
assistant at surgery modifier are paid 16 percent of the PFS amount for
that service; therefore, the utilization file is modified to only
account for 16 percent of any service that contains the assistant at
surgery modifier. Similarly, for those services to which volume
adjustments are made to account for the payment modifiers, time
adjustments are applied as well. For time adjustments to surgical
services, the intraoperative portion in the work time file is used;
where it is not present, the intraoperative percentage from the payment
files used by contractors to process Medicare claims is used instead.
Where neither is available, we use the payment adjustment ratio to
adjust the time accordingly. Table 2 details the manner in which the
modifiers are applied.
Table 2--Application of Payment Modifiers to Utilization Files
----------------------------------------------------------------------------------------------------------------
Modifier Description Volume adjustment Time adjustment
----------------------------------------------------------------------------------------------------------------
80,81,82.......................... Assistant at Surgery... 16%........................ Intraoperative
portion.
AS................................ Assistant at Surgery-- 14% (85% * 16%)............ Intraoperative
Physician Assistant. portion.
50 or LT and RT................... Bilateral Surgery...... 150%....................... 150% of work time.
51................................ Multiple Procedure..... 50%........................ Intraoperative
portion.
52................................ Reduced Services....... 50%........................ 50%.
53................................ Discontinued Procedure. 50%........................ 50%.
54................................ Intraoperative Care Preoperative + Preoperative +
only. Intraoperative Percentages Intraoperative
on the payment files used portion.
by Medicare contractors to
process Medicare claims.
55................................ Postoperative Care only Postoperative Percentage on Postoperative portion.
the payment files used by
Medicare contractors to
process Medicare claims.
62................................ Co-surgeons............ 62.5%...................... 50%.
66................................ Team Surgeons.......... 33%........................ 33%.
----------------------------------------------------------------------------------------------------------------
[[Page 52986]]
We also make adjustments to volume and time that correspond to
other payment rules, including special multiple procedure endoscopy
rules and multiple procedure payment reductions (MPPRs). We note that
section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments
for multiple imaging procedures and multiple therapy services from the
BN calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These
MPPRs are not included in the development of the RVUs.
For anesthesia services, we do not apply adjustments to volume
since we use the average allowed charge when simulating RVUs;
therefore, the RVUs as calculated already reflect the payments as
adjusted by modifiers, and no volume adjustments are necessary.
However, a time adjustment of 33 percent is made only for medical
direction of two to four cases since that is the only situation where a
single practitioner is involved with multiple beneficiaries
concurrently, so that counting each service without regard to the
overlap with other services would overstate the amount of time spent by
the practitioner furnishing these services.
Work RVUs: The setup file contains the work RVUs from this
final rule.
(6) Equipment Cost per Minute
The equipment cost per minute is calculated as:
(1/(minutes per year * usage)) * price * ((interest rate/(1-(1/((1 +
interest rate) [caret] life of equipment)))) + maintenance)
Where:
minutes per year = maximum minutes per year if usage were continuous
(that is, usage = 1); generally 150,000 minutes.
usage = variable, see discussion in this final rule.
price = price of the particular piece of equipment.
life of equipment = useful life of the particular piece of
equipment.
maintenance = factor for maintenance; 0.05.
interest rate = variable, see discussion in this final rule.
Usage: We currently use an equipment utilization rate assumption of
50 percent for most equipment, with the exception of expensive
diagnostic imaging equipment, for which we use a 90 percent assumption
as required by section 1848(b)(4)(C) of the Act.
Stakeholders have often suggested that particular equipment items
are used less frequently than 50 percent of the time in the typical
setting and that CMS should reduce the equipment utilization rate based
on these recommendations. We appreciate and share stakeholders'
interest in using the most accurate assumption regarding the equipment
utilization rate for particular equipment items. However, we believe
that absent robust, objective, auditable data regarding the use of
particular items, the 50 percent assumption is the most appropriate
within the relative value system. We welcome the submission of data
that illustrates an alternative rate.
Comment: One commenter stated that most ophthalmology diagnostic
equipment is in use far less than 50 percent of the time. The commenter
indicated that they had developed a survey instrument that asked
ophthalmic technicians to provide time usage estimates for the 16 most-
utilized pieces of diagnostic testing equipment. The commenter stated
that their preliminary survey results produced a utilization rate of 22
percent, much lower than the 50 percent assumption currently used by
CMS. The commenter suggested that CMS should work with the RUC to do a
robust survey to help determine a more valid utilization rate,
including the possibility of specialty-specific equipment utilization
rates.
Response: We are always looking for more accurate information to
improve our PE methodology. We appreciate and share stakeholders'
interest in using the most accurate assumption regarding the equipment
utilization rate for particular equipment items, and we will review any
information that the RUC's PE Subcommittee or other stakeholders are
willing to submit through the public comment process. We concur with
the commenter that a wide-ranging survey or similar study designed to
address the subject of equipment utilization rates would be an
appropriate tool to investigate this subject in further detail. At the
moment, we believe that absent robust, objective, auditable data
regarding the use of particular items, the 50 percent assumption is the
most appropriate within the relative value system. We welcome the
further submission of data that illustrates an alternative rate.
Maintenance: This factor for maintenance was finalized in the CY
1998 PFS final rule with comment period (62 FR 33164).
Comment: Several commenters addressed the issue of equipment
maintenance costs. One commenter stated that the current maintenance
percentage of 5 percent across all types of medical equipment does not
adequately address the maintenance costs of imaging equipment in
general and particularly not for advanced imaging modalities like CT
and MRI. This commenter stated that a CT scanner would have an
estimated annual maintenance cost of 7.2 percent. Another commenter
supported our willingness to investigate potential avenues for
determining variable equipment maintenance costs across a broad range
of equipment items. The commenter stated that the standard equipment
rate assumption fails to appreciate the significant costs associated
with the maintenance of highly technical and particularly complex
equipment items, and indicated that that CMS should not persist in an
inaccurate approach while it collects additional data.
Response: We appreciate the additional information regarding
equipment maintenance rates from the commenters. As we previously
stated in the CY 2016 final rule with comment period (80 FR 70897), we
agree with the commenters that we do not believe the annual maintenance
factor for all equipment is precisely 5 percent, and we concur that the
current rate likely understates the true cost of maintaining some
equipment. We also believe it likely overstates the maintenance costs
for other equipment. When we solicited comments regarding sources of
data containing equipment maintenance rates, commenters were unable to
identify an auditable, robust data source that could be used by CMS on
a wide scale. We do not believe that voluntary submissions regarding
the maintenance costs of individual equipment items would be an
appropriate methodology for determining costs. As a result, in the
absence of publicly available datasets regarding equipment maintenance
costs or another systematic data collection methodology for determining
maintenance factor, we do not believe that we have sufficient
information at present to adopt a variable maintenance factor for
equipment cost per minute pricing. We continue to investigate potential
avenues for determining equipment maintenance costs across a broad
range of equipment items.
Interest Rate: In the CY 2013 PFS final rule with comment period
(77 FR 68902), we updated the interest rates used in developing an
equipment cost per minute calculation (see 77 FR 68902 for a thorough
discussion of this issue). The interest rate was based on the Small
Business Administration (SBA) maximum interest rates for different
categories of loan size (equipment cost) and maturity (useful life). We
did not propose any changes to these interest rates for CY 2018. The
interest rates are listed in Table 3.
[[Page 52987]]
Table 3--SBA Maximum Interest Rates
------------------------------------------------------------------------
Useful Interest
Price life rate
(years) (%)
------------------------------------------------------------------------
<$25K............................................... <7 7.50
$25K to $50K........................................ <7 6.50
>$50K............................................... <7 5.50
<$25K............................................... 7+ 8.00
$25K to $50K........................................ 7+ 7.00
>$50K............................................... 7+ 6.00
------------------------------------------------------------------------
3. Changes to Direct PE Inputs for Specific Services
This section focuses on specific PE inputs. The direct PE inputs
are included in the CY 2018 direct PE input database, which is
available on the CMS Web site under downloads for the CY 2018 PFS final
rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
(a) PE Inputs for Digital Imaging Services
In the CY 2017 PFS final rule (81 FR 80179 through 80184), we
finalized our proposal to add a professional PACS workstation (ED053)
used for interpretation of digital images to a series of CPT codes and
to address costs related to the use of film that had previously been
incorporated as direct PE inputs for these services. We finalized the
following criteria for the inclusion of a professional PACS
workstation:
We did not add the professional PACS workstation to any
code that currently lacks a technical PACS workstation (ED050) or lacks
a work RVU. We continue to believe that procedures that do not include
a technical workstation, or do not have physician work, would not
require a professional workstation.
We did not add the professional PACS workstation to add-on
codes. Because the base codes include equipment minutes for the
professional PACS workstation, we continue to believe it would be
duplicative to add additional equipment time for the professional PACS
workstation in the add-on code.
We also did not add the professional PACS workstation to
image guidance codes where the dominant provider is not a radiologist
according to the most recent year of claims data, because we believe a
single technical PACS workstation would be more typical in those cases.
We agreed with commenters that because the clinical
utility of the PACS workstation is not necessarily limited to
diagnostic services, there may be therapeutic codes where it would be
reasonable to assume its use to be typical. Based on information
provided by commenters and our own medical review, we stated that we
believe that the use of the professional PACS workstation is typical
for many of the specific codes that were identified. We added the
workstation to many of the therapeutic codes requested by commenters,
specifically CPT codes listed outside the 70000 series, where we agreed
that use of the professional PACS workstation was typical.
For CPT codes in the 80000 and 90000 series, we expressed
our concerns about whether it is appropriate to include the technical
PACS workstation in many of these services. PACS workstations were
created for imaging purposes, but many of these services that include a
technical PACS workstation do not appear to make use of imaging.
Although we did not remove the technical PACS workstation from these
codes at that time, we did not believe that a professional PACS
workstation should be added to these procedures.
Prior to the publication of this CY 2018 PFS proposed rule, a
stakeholder expressed concern about our decision not to include the
professional PACS workstation in a series of vascular ultrasound codes
that use technical PACS workstations. The stakeholder indicated that
the vascular ultrasound codes in question do make use of a professional
PACS workstation, and that the dominant specialty provider requirement
(that is, that the code's dominant specialty provider be diagnostic
radiology) would exclude codes for which the professional PACS
workstation is typical based on a mistaken assumption. The stakeholder
stated that to furnish vascular ultrasound services following the
transition from film to digital imaging, both a technical and a
professional PACS workstation are required, regardless of whether the
practitioner furnishing the service is a radiologist, cardiologist,
neurologist, or vascular surgeon.
We appreciate the submission of this additional information
regarding the use of the professional PACS workstation in vascular
ultrasound codes. Therefore, we solicited comments regarding whether or
not the use of the professional PACS workstation would be typical in
the following list of CPT and HCPCS codes. The codes brought to our
attention by the stakeholder are CPT codes 93880, 93882, 93886, 93888,
93890, 93892, 93893, 93922, 93923, 93924, 93925, 93926, 93930, 93931,
93965, 93970, 93971, 93975, 93976, 93978, 93979, 93980, 93981, 93990,
and 76706, and HCPCS code G0365. We considered information submitted in
comments to determine whether the professional PACS workstation should
be included as a direct PE input for these codes.
The following is a summary of the public comments received
regarding whether or not the use of the professional PACS workstation
would be typical in the previous list of CPT and HCPCS codes and our
responses:
Comment: Several commenters stated that the finalized policy in CY
2017 that did not add the professional PACS workstation to image
guidance codes where the dominant practitioner is not a radiologist was
an arbitrary decision. The commenters stated that CMS did not provide
any rationale for this policy, and that for many services, both a
technical and a professional PACS workstation would be typically used
regardless of whether the practitioner performing the service is a
radiologist or in another specialty. These commenters urged CMS to add
a professional PACS workstation in services where its use would be
typical without concern for whether diagnostic radiology is the
dominant provider.
Response: We agree with the commenters that equipment allocated to
each code should be determined based on the resources typically
required to furnish the service. In general, we believe that examining
Medicare claims data for dominant specialty is a useful and data-driven
approach to making educated assumptions regarding typical resources
involved in furnishing particular procedures. However, in this case, we
are persuaded by commenters who stated that other specialties, outside
of diagnostic radiology, utilize the professional PACS workstation.
After reviewing the information supplied by the commenters, we agree
the use of both a technical and a professional PACS workstation may be
typical in some services where diagnostic radiology is not the dominant
provider. We welcome feedback from stakeholders in identifying
additional services where the use of a professional PACS workstation
would be typical.
Comment: One commenter disagreed with the exclusion of add-on codes
from the list of codes that included a professional PACS workstation.
The commenter stated that the add-on codes require additional time to
perform and therefore more time with the technical PACS workstation for
the technician, as well as additional time for the review and
interpretation performed by the
[[Page 52988]]
physician using the professional PACS workstation.
Response: We disagree with the commenter. We continue to believe it
would be duplicative to add additional equipment time for the
professional PACS workstation in the add-on code, as the base codes
already include equipment time for the practitioner's use following the
service.
Comment: Many commenters stated that the use of a professional PACS
workstation would be typical in the 26 CPT codes detailed previously.
Commenters stated that in the wake of the transition from film to
digital imaging, use of both a technical and a professional PACS
workstations has become typical for many diagnostic imaging services,
including vascular ultrasound and digital pathology services. One
commenter indicated that the use of the professional PACS workstation
served a vital part in coordination of care for their treatment of
vascular access issues related to ESRD patients. Another commenter
stated that HCPCS code G0365 may have been mistakenly included on this
list, as it already includes a professional PACS workstation added in
CY 2017, while CPT code 93965 should not be considered for the
professional PACS workstation as the code was previously deleted.
Response: We agree with the commenters that the use of the
professional PACS workstation would be typical in 21 of the 26 codes
listed in the proposed rule. As mentioned by one commenter, CPT code
93965 has been deleted while code G0365 already includes a professional
PACS workstation. We disagree with adding a professional PACS
workstation to CPT codes 93922, 93923, and 93924 because these codes do
not include a technical PACS workstation and we continue to believe
that procedures that do not include a technical workstation would not
require a professional workstation. We will assign equipment time for
the professional PACS workstation in the nonfacility setting according
to the equipment time formula finalized in CY 2017. For diagnostic
codes, we are assigning equipment minutes equal to half the preservice
physician work time plus the full intraservice physician work time,
consistent with the previously finalized policy. For the relatively
smaller group of diagnostic codes with no service period time
breakdown, we are assigning equipment time equal to half of the total
physician work time, consistent with the previously finalized policy.
The equipment time to be added is shown in Table 4.
Table 4--Additional Codes With Professional PACS Workstation
------------------------------------------------------------------------
ED053
HCPCS Procedure type minutes
------------------------------------------------------------------------
93880......................... Diagnostic................. 18
93882......................... Diagnostic................. 13
93886......................... Diagnostic................. 20
93888......................... Diagnostic................. 13
93890......................... Diagnostic................. 20
93892......................... Diagnostic................. 25
93893......................... Diagnostic................. 25
93925......................... Diagnostic................. 18
93926......................... Diagnostic................. 13
93930......................... Diagnostic................. 18
93931......................... Diagnostic................. 13
93970......................... Diagnostic................. 17
93971......................... Diagnostic................. 12
93975......................... Diagnostic................. 23
93976......................... Diagnostic................. 18
93978......................... Diagnostic................. 18
93979......................... Diagnostic................. 13
93980......................... Diagnostic................. 21
93981......................... Diagnostic................. 10
93990......................... Diagnostic................. 14
76706......................... Diagnostic................. 13
------------------------------------------------------------------------
Comment: One commenter stated that the costs associated with
storing digital images should be included as a direct PE. The commenter
noted that CMS treated film as a supply item for purposes of direct
cost determination and cited an MRI study in the 2010 direct PE
database with 12 pieces of 14 x 17 film at a price of $1.17 each or
$14.04. The commenter stated that this film was not replaced and that
digital imaging studies need to be recorded and then archived. The
commenter suggested that storage costs for digital images should be
added as a maintenance percentage for digital imaging services.
Response: We disagree with the commenter that the costs associated
with storing digital images are excluded from digital imaging services,
as these costs are incorporated into the indirect PE methodology that
cover administrative costs and office rent. We do not pay separately
for the storage of digital images as these expenses are not allocable
to individual services, just as we do not explicitly incorporate the
storage costs of electronic health records (EHRs) as direct PE inputs
for the range of practitioners that use EHRs. We understand and agree
that we previously treated film itself as direct PE input. However, the
film was allocable to an individual patient. We believe that the better
analog for the storage of images under the previous assumptions would
be the office cabinets and office space in which the film was stored.
These items were clearly considered to be indirect PE expenses and,
therefore, such costs are included in the specialty-specific data that
is used to allocate indirect PE RVUs. We previously replaced the direct
PE components of imaging services during the film-to-digital transition
that took place in CY 2015 (79 FR 67561).
Comment: One commenter recommended that CMS revisit its definition
of room time for imaging procedures. Under the current policy, room
time for imaging studies is defined as the time it takes to acquire the
images plus any additional time that the piece of equipment is not
available for use for another patient due to its use during the
designated procedure. The commenter stated that this definition was
inconsistent with how imaging centers actually function, as most
patient-related activities take place in the imaging room with the
involvement of multiple technologists. The commenter suggested that CMS
should return to the previous definition, in which equipment time for
highly technical equipment was based on total technologist time.
Response: We disagree with the commenter regarding the current
standard equipment time formula for highly technical equipment. As we
wrote in the CY 2011 final rule with comment period (75 FR 73350),
certain highly technical pieces of equipment and equipment rooms are
less likely to be used by a clinician over the full course of a
procedure and are typically available for other patients during time
that may still be in the intraservice portion of the service. When we
identify these services, we adjust those equipment times accordingly.
For example, CPT code 74178 (Computed tomography, abdomen and pelvis;
without contrast material in more than one body region) includes 3
minutes of intra-service clinical labor time associated with obtaining
the patient's consent for the procedure. Since we believe that it would
be atypical for this activity to occur within the CT room, we believe
these 3 minutes should not be attributed to the CT room. We agree with
the commenter that the standard formula used to determine equipment
time for highly technical equipment may not be typical for all
services, which is why we evaluate equipment time on a case-by-case
basis as services are reviewed. We appreciate the information submitted
by the commenter, and we will take these comments under consideration
as we evaluate codes on an individual basis.
After consideration of comments received, we are finalizing the
addition of a professional PACS workstation to the codes listed in
Table 4 with the equipment time detailed.
[[Page 52989]]
(2) Standardization of Clinical Labor Tasks
As we noted in the CY 2015 PFS final rule with comment period (79
FR 67640-67641), we continue to make improvements to the direct PE
input database to provide the number of clinical labor minutes assigned
for each task for every code in the database instead of only including
the number of clinical labor minutes for the preservice, service, and
postservice periods for each code. In addition to increasing the
transparency of the information used to set PE RVUs, this improvement
would allow us to compare clinical labor times for activities
associated with services across the PFS, which we believe is important
to maintaining the relativity of the direct PE inputs. This information
would facilitate the identification of the usual numbers of minutes for
clinical labor tasks and the identification of exceptions to the usual
values. It would also allow for greater transparency and consistency in
the assignment of equipment minutes based on clinical labor times.
Finally, we believe that the information can be useful in maintaining
standard times for particular clinical labor tasks that can be applied
consistently to many codes as they are valued over several years,
similar in principle to the use of physician preservice time packages.
We believe such standards would provide greater consistency among codes
that share the same clinical labor tasks and could improve relativity
of values among codes. For example, as medical practice and
technologies change over time, changes in the standards could be
updated simultaneously for all codes with the applicable clinical labor
tasks, instead of waiting for individual codes to be reviewed.
The following is a summary of the public comments received
regarding the standardization of clinical labor tasks and our
responses:
Comment: One commenter supported the efforts of the AMA RUC to
standardize clinical labor activities in the new PE worksheet and urged
CMS to accept these standards.
Response: We appreciate the efforts to establish greater
organizational consistency through the RUC's use of the new PE
worksheet and new clinical labor activity codes in developing and
making recommendations to CMS.
Comment: Several commenters stated that, while they supported the
revisions to the direct PE database providing the number of clinical
labor minutes assigned for each clinical labor activity for each code,
they had concerns regarding the over-standardization of clinical labor
activities. These commenters indicated that each service requires
different clinical labor resources and creating standard times is not
possible for all clinical labor activities. Commenters stated that the
RUC's PE Subcommittee is the entity best suited to make service-level
determinations for clinical labor, and that blanket changes to
standardize clinical labor activities outside of RUC review would lead
to misvaluation of codes.
Response: We agree with the commenters that there are often
important differences between services and that no two services are
necessarily identical. We also acknowledge that there is a balance
between establishing standards for clinical labor activities and the
need for individual review of each code. We concur with the commenters
that some services require greater or less time than the clinical labor
standards, and we have frequently finalized clinical labor times
outside the standard values. The standard times for clinical labor
activities are a starting point for our clinical review of individual
services, not necessarily an ending point. As we have written in past
rulemaking, we believe that the establishment of standard times helps
to facilitate greater transparency of information and maintain
consistency in review patterns over time. Our goal is to maintain
relativity among services, and we believe that the creation of clinical
labor standards helps to facilitate that goal.
Comment: One commenter stated that the proposed standardized
clinical labor times for CT and MRI codes required additional time due
to a need to assess patients for any special needs, review screening
sheets with patients, and obtain a clinical history from the patient.
Response: When reviewing clinical labor times for individual codes,
we typically work closely with the recommendations provided by the RUC,
which did not include additional clinical labor time for these specific
activities in these services. While we appreciate the additional
information from the commenter, we do not agree that it would serve
overall PFS relativity to include additional clinical labor time for
these services based on this rationale.
In the following paragraphs, we address a series of issues related
to clinical labor tasks, particularly relevant to services currently
being reviewed under the misvalued code initiative.
a. Preservice Clinical Labor for 0-Day and 10-Day Global Services
Several years ago, the RUC's PE Subcommittee reviewed the
preservice clinical labor times for CPT codes with 0-day and 10-day
global periods. The RUC concluded that these codes are assumed to have
no preservice clinical staff time (standard time of 0 minutes) unless
the specialty can provide evidence that the preservice time is
appropriate. In other words, for minor procedures, it is assumed that
there is no clinical staff time typically spent preparing for the
specific procedure prior to the patient's arrival. However, we note
that for CY 2018, 41 of the 53 reviewed codes with 0-day or 10-day
global periods include preservice clinical labor of some kind,
suggesting that it is typical for clinical staff to prepare for the
procedure prior to the patient's arrival. As we review misvalued codes,
we believe that the general adherence to values that we have
established as standards supports relativity within the PFS. Because 77
percent of the reviewed codes for the current calendar year deviate
from the ``standard,'' we sought comment on the value and appropriate
application of the standard in our review of RUC recommendations in
future rulemaking. In reviewing the inputs included in the direct PE
inputs database, we found that for the 1,142 total 0-day global codes,
741 of them had preservice clinical labor of some kind (65 percent). We
also noticed a general correlation between preservice clinical labor
time and the recent review. We sought comment specifically on whether
the standard preservice clinical labor time of 0 minutes should be
consistently applied for 0-day and 10-day global codes in future
rulemaking.
The following is a summary of the public comments received
regarding whether the standard preservice clinical labor time of 0
minutes should be consistently applied for 0-day and 10-day global
codes in future rulemaking and our responses:
Comment: Many commenters opposed eliminating clinical staff
preservice time from all 0-day and 10-day global procedures in future
rulemaking. Several commenters stated that although it is accurate to
assume that no clinical staff time is necessary for minor procedures,
it is no longer true that all 0-day and 10-day globals can be
classified as minor procedures, as increasingly complex services are
now performed using this global period. For example, there are several
cardiothoracic surgery procedures that in the past would have been
valued as
[[Page 52990]]
90-day global services but instead were implemented as 0-day global
procedures to allow additional flexibility in the delivery of patient
care. One commenter stated that the ``trend'' identified in the
proposed rule occurred only because of the significant number of 0-day
endoscopy and interventional codes that have recently been reviewed.
Other commenters stated that the standard preservice clinical labor
time of 0 minutes is only applicable if specialties cannot provide
evidence of the need for preservice clinical labor, and that the rise
in preservice clinical labor time indicated the growing recognition
that the use of clinical staff is typical for these services. Many
commenters stated that the RUC's PE Subcommittee should review the
evidence on a case-by-case basis to determine if individual services
justify preservice clinical labor time. Commenters urged CMS to work
with the RUC to identify circumstances where deviations from the
standard clinical labor times would be appropriate and develop clear
definitions and criteria that support compelling reasons for clinical
staff time that deviates from the standard for 0-day and 10-day global
procedures. A few commenters, including the RUC, acknowledged that the
high number of preservice clinical labor exceptions raised the question
of the utility of the standard given this high number of exemptions.
Response: We appreciate the responses from the commenters. We note
that several commenters also acknowledged the problematic nature of
having so many exceptions to the established standard for preservice
clinical labor. We appreciate in particular the additional information
regarding the increasing use of the 0-day and 10-day global periods for
procedures that are not minor in nature. In light of this information,
we agree with the commenters who suggested that there is a need to
identify circumstances where deviations from the standard clinical
labor times would be appropriate and develop clear definitions and
criteria for these situations. If an increasingly large number of major
procedures are performed using the 0-day and 10-day global periods, we
believe that there will be a need for the establishment of new
guidelines for the typical allotment of preservice clinical labor. We
agree with the commenters that preservice clinical labor must be
determined on an individual basis based on the resources typically
required to furnish the service. However, the need for individual
review of services does not preclude the development of standards
which, as we stated above, helps to facilitate greater transparency of
information and maintain consistency in review patterns over time.
After consideration of comments received, we do not believe that
the standard preservice clinical labor time of 0 minutes should be
consistently applied for 0-day and 10-day global codes in future
rulemaking. We look forward to working with stakeholders and seeing
their recommendations for preservice clinical labor that maintain
relativity among the different kind of procedures classified as 0-day
and 10-day globals.
b. Obtain Vital Signs Clinical Labor
The direct PE inputs for each CPT code paid under the PFS include
minutes assigned to a series of standard clinical labor tasks assumed
to be typical for the service in question. The minutes assigned to each
of these tasks for each CPT code have been developed over several
decades, and what was previously considered to be a standard value in
the review of the codes has changed over time. Because each year we
perform a detailed review of all of the inputs for only several hundred
of the over 7,000 CPT codes paid under the PFS, valuation for
individual services can be influenced by shifts in review standards
over time rather than purely based on changes in practice.
For example, we traditionally assigned a clinical labor time of 3
minutes for the ``Obtain vital signs'' clinical labor activity, based
on the amount of time typically required to check a patient's vitals.
Over time, that number of minutes has increased as codes are reviewed.
For example, many of the reviewed codes for the current CY 2018
rulemaking cycle have a recommended clinical labor time of 5 minutes
for ``Obtain vital signs,'' based on the understanding that these
services are measuring two additional vital signs: the patient's height
and weight. We do not have any reason to believe that measuring a
patient's height and weight is only typical for services described by
recently reviewed codes. Instead, we believe that the review standards
have changed, perhaps in conjunction with changes in medical practice,
and that the change in the minutes assigned for the ``Obtain vital
signs'' task for newer-reviewed services is detrimental to relativity
among PFS services.
Therefore, to preserve relativity among the PFS codes, we proposed
to assign 5 minutes of clinical labor time for all codes that include
the ``Obtain vital signs'' task, regardless of the date of last review.
We proposed to assign this 5 minutes of clinical labor time for all
codes that include at least 1 minute previously assigned to this task.
We also proposed to update the equipment times of the codes with this
clinical labor task accordingly to match the changes in clinical labor
time. For codes that were not recently reviewed and for which we lacked
a breakdown of how the equipment time was derived from the clinical
labor tasks, we could not determine if the equipment time included time
assigned for the ``Obtain vital signs'' task. In these cases, we
proposed to adjust the equipment time of any equipment item that
matched the clinical labor time of the full service period to match the
change in the ``Obtain vital signs'' clinical labor time. The list of
all codes affected by these proposed vital signs changes to direct PE
inputs is available on the CMS Web site under downloads for the CY 2018
PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
The following is a summary of the public comments received on the
list of all codes affected by these proposed vital signs changes to
direct PE inputs proposals and our responses:
Comment: Many commenters supported the CMS proposal. Commenters
agreed that these differences in the minutes assigned to the ``Obtain
vital signs'' clinical labor task appeared to be attributed to
variances in review standards over time rather than reflecting actual
variations in practice. One commenter stated that medical practice
typically requires measurement of height and weight when vital signs
are measured, while another commenter stated that the new standard time
would be an administrative simplification for stakeholders and help
streamline reviews. These commenters urged CMS to finalize the proposal
to help preserve relativity between PFS codes.
Response: We appreciate the support from the commenters for the
proposal.
Comment: Other commenters disagreed with the proposal to establish
5 minutes as the new clinical labor standard for the ``Obtain vital
signs'' task. These commenters stated that the RUC PE Subcommittee's
standard for vital signs clinical labor, based on the number of vital
signs being taken, remained accurate and was the best way to make sure
that individual codes are allocated the correct amount of time. These
commenters were opposed to changing the clinical labor time of a large
number of codes at once, and stressed the need for individual review
[[Page 52991]]
of each service. Commenters urged CMS not to finalize this proposal and
suggested the issue should be referred to the RUC and its Practice
Expense Advisory Committee for further review and input.
Response: We generally agree with commenters that the
determinations for individual clinical labor activities are typically
made at the code level, such as those recommended by the RUC's PE
subcommittee. Therefore, we are not finalizing our proposal to use 5
minutes as the universal input for this clinical labor task. However,
since even the comments opposing the proposal did not suggest that the
clinical labor associated with taking vital signs has changed over
time, only the review standards associated with them, we will assign 5
minutes as the input for all codes that include the ``Obtain vital
signs'' task for CY 2018, as proposed. For future rulemaking we will
consider code-level recommendations that will help distinguish services
that may require fewer or greater than 5 minutes for this activity. We
believe that finalizing 5 minutes for the codes as proposed will serve
to mitigate the detrimental impact of review standards shifting over
time while preserving the principle that the number of minutes involved
in obtaining vital signs may vary for different services.
Comment: One commenter asked if CMS would accept vital sign data
from fitness wearable devices such as an Apple watch, Garmin, or
Fitbit.
Response: Our proposal concerns the number of minutes assumed to be
involved in obtaining vital signs for purposes of PFS ratesetting and
is not intended to establish requirements regarding how vital signs are
obtained.
After consideration of comments received, we are not finalizing our
proposal to establish 5 minutes as the new standard for the ``Obtain
vital signs'' clinical labor task. However, since we continue to
believe that the review standards associated with the clinical labor
time for obtaining vital signs have changed over time, we will assign 5
minutes as the input for all codes that include the ``Obtain vital
signs'' task for CY 2018, as proposed.
c. Establishment of Clinical Labor Activity Codes
Historically, the RUC has submitted a ``PE worksheet'' that details
the recommended direct PE inputs for our use in developing PE RVUs. The
format of the PE worksheet has varied over time and among the medical
specialties developing the recommendations. These variations have made
it difficult for both the RUC's development and our review of code
values for individual codes. Beginning for the CY 2019 PFS rulemaking
cycle, we understand that the RUC intends to mandate the use of a new
PE worksheet for purposes of their recommendation development process
that standardizes the clinical labor tasks and assigns them a clinical
labor activity code. We believe the RUC's use of the new PE worksheet
in developing and submitting recommendations to us would, in turn, help
us to simplify and standardize the hundreds of different clinical labor
tasks currently listed in our direct PE database.
To help facilitate this transition to the new clinical labor
activity codes, we developed a crosswalk to link the old clinical labor
tasks to the new clinical labor activity codes. Our crosswalk is for
informational purposes only, and would not change either the direct PE
input values or the PE RVUs for codes. Instead, we hope that the
crosswalk would help us to translate the sprawling, existing data set
into a condensed version that would significantly improve the
standardization of clinical labor recommendations and improve the
ability of commenters to identify concerns with our proposed valuation.
For CY 2018 rulemaking, we are displaying two versions of the Labor
Task Detail public use file: One version with the old listing of
clinical labor tasks, and one with the same tasks as described by the
new listing of clinical labor activity codes. These lists are available
on the CMS Web site under downloads for the CY 2018 PFS final rule at
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
(3) Equipment Recommendations for Scope Systems
During our routine reviews of direct PE input recommendations, we
have regularly found unexplained inconsistencies involving the use of
scopes and the video systems associated with them. Some of the scopes
include video systems bundled into the equipment item, some of them
include scope accessories as part of their price, and some of them are
standalone scopes with no other equipment included. It is not always
clear which equipment items related to scopes fall into which of these
categories. We have also frequently found anomalies in the equipment
recommendations, with equipment items that consist of a scope and video
system bundle recommended, along with a separate scope video system.
Based on our review, the variations do not appear to be consistent with
the different code descriptions.
To promote appropriate relativity among the services and facilitate
the transparency of our review process, during review of recommended
direct PE inputs for the CY 2017 PFS proposed rule, we developed a
structure that separates the scope and the associated video system as
distinct equipment items for each code. Under this approach, we
proposed standalone prices for each scope, and separate prices for the
video systems that are used with scopes. We proposed to define the
scope video system as including: (1) A monitor; (2) a processor; (3) a
form of digital capture; (4) a cart; and (5) a printer. We believe that
these equipment components represent the typical case for a scope video
system. Our model for this system was the ``video system, endoscopy
(processor, digital capture, monitor, printer, cart)'' equipment item
(ES031), which we proposed to re-price as part of this separate pricing
approach. We obtained current pricing invoices for the endoscopy video
system as part of our investigation of these issues involving scopes,
which we proposed to use for this re-pricing. We understand that there
may be other accessories associated with the use of scopes; we proposed
to separately price any scope accessories, and individually evaluate
their inclusion or exclusion as direct PE inputs for particular codes
as usual under our current policy based on whether they are typically
used in furnishing the services described by the particular codes.
We also proposed standardizing refinements to the way scopes have
been defined in the direct PE input database. We believe that there are
four general types of scopes: Non-video scopes; flexible scopes; semi-
rigid scopes, and rigid scopes. Flexible scopes, semi-rigid scopes, and
rigid scopes would typically be paired with one of the scope video
systems, while the non-video scopes would not. The flexible scopes can
be further divided into diagnostic (or non-channeled) and therapeutic
(or channeled) scopes. We proposed to identify for each anatomical
application: (1) A rigid scope; (2) a semi-rigid scope; (3) a non-video
flexible scope; (4) a non-channeled flexible video scope; and (5) a
channeled flexible video scope. We proposed to classify the existing
scopes in our direct PE database under this classification system, to
improve the transparency of our review process and improve appropriate
relativity among the services. We planned to propose
[[Page 52992]]
input prices for these equipment items through future rulemaking.
We proposed these changes only for the reviewed codes for CY 2017
that made use of scopes, along with updated prices for the equipment
items related to scopes utilized by these services. But, we did not
propose to apply these policies to codes with inputs reviewed prior to
CY 2017. We also solicited comment on this separate pricing structure
for scopes, scope video systems, and scope accessories, which we could
consider proposing to apply to other codes in future rulemaking. In
response to comments, we finalized the addition of a digital capture
device to the endoscopy video system (ES031) in the CY 2017 PFS final
rule. We finalized our proposal to price the system at $33,391, based
on component prices of $9,000 for the processor, $18,346 for the
digital capture device, $2,000 for the monitor, $2,295 for the printer,
and $1,750 for the cart. We also finalized a price of $16,843.87 for
the stroboscopy system scope accessory (ES065). We did not finalize
price increases for a series of other scopes and scope accessories, as
the invoices submitted for these components indicated that they are
different forms of equipment with different product IDs and different
prices. We did not receive any data to indicate that the equipment on
the newly submitted invoices was more typical in its use than the
equipment that we were currently using for pricing.
We did not make further changes to existing scope equipment in CY
2017 in order to allow the RUC's PE Subcommittee the opportunity to
provide feedback. However, we believed there was some miscommunication
on this point, as the RUC's PE Subcommittee workgroup that was created
to address scope systems stated that no further action was required
following the finalization of our proposal. Therefore, we made further
proposals to continue clarifying scope equipment inputs, and sought
comments regarding the new set of scope proposals. We welcomed feedback
from all stakeholders, including practitioners with direct experience
in the use of scope equipment.
We sought comment on several potential categories of scope system
PE inputs. We are considering creating a single scope equipment code
for each of the five categories detailed in this rule: (1) A rigid
scope; (2) a semi-rigid scope; (3) a non-video flexible scope; (4) a
non-channeled flexible video scope; and (5) a channeled flexible video
scope. Under the current classification system, there are many
different scopes in each category depending on the medical specialty
furnishing the service and the part of the body affected. We believe
that the variation between these scopes is not significant enough to
warrant maintaining these distinctions, and we believe that creating
and pricing a single scope equipment code for each category would help
provide additional clarity. We sought public comment on the merits of
this potential scope organization, as well as any pricing information
regarding these five new scope categories.
For CY 2018, we proposed two minor changes to PE inputs related to
scopes. We proposed to add an LED light source into the cost of the
scope video system (ES031), which would remove the need for a separate
light source in these procedures. If this proposal were to be
finalized, we would remove the equipment time for the separate light
source from CPT codes that include the scope video system. We also
proposed an increase to the price of the scope video system of
$1,000.00 to cover the expense of miscellaneous small equipment
associated with the system that falls below the threshold of individual
equipment pricing as scope accessories (such as cables, microphones,
foot pedals, etc.) We sought comments on the inclusion of the LED light
in the scope video system, and the appropriate pricing of the system
with the inclusion of these additional equipment items.
We anticipate adopting detailed changes to scope systems at the
code level through rulemaking for CY 2019, because we believe that
additional feedback from expert stakeholders will improve the details
of the proposed changes. We did not propose any additional pricing
changes to scope equipment for CY 2018 due to the proposed
reorganization into a single type of scope equipment for each of the
five scope categories. However, we would consider updating prices for
these equipment items through the public request process for price
updates, or based on information submitted as part of RUC
recommendations.
The following is a summary of the public comments received on the
continued organization of scope equipment and our responses:
Comment: Many commenters disagreed with the CMS proposal to create
and price a single scope equipment code for each category. Commenters
stated that there were significant differences in the scopes used by
different specialties, and the proposal to establish a single scope for
each category would not sufficiently capture variations across
specialties in terms of typical scopes and typical costs. As an
example, one commenter stated that the price difference between scopes
could be as large as $10,000. Many commenters suggested that CMS should
create packages on a per-specialty basis for these five categories of
scopes, as applicable.
Response: In light of the information supplied by commenters
regarding the significant differences in price and usage across
specialties, we will not finalize our proposal to create and price a
single scope equipment code for each of the five categories previously
identified.
Comment: Commenters supported the CMS proposal to add an LED light
source and miscellaneous costs into the price of the scope video system
(ES031). Commenters indicated that the addition of the light and
$1,000.00 for small various small items like foot pedals and
microphones would more accurately describe the resource costs of the
scope video system.
Response: We appreciate the comments supporting the proposal.
However, we are not finalizing the proposal to add an LED light source
and an increase of $1,000 for miscellaneous small equipment to the
price of scope video systems for CY 2018. We intend to update the price
of the scope video system with these changes for CY 2019 as part of the
scope reorganization project.
Comment: Many commenters agreed with the proposal to delay
implementation of these proposed changes until CY 2019 and encouraged
CMS to request that the RUC review this issue and provide guidance on
the correct pricing.
Response: We agree that the anticipated delay on implementation
until CY 2019 will allow additional time for stakeholders to provide
recommendations on the proper organization and pricing of scope
equipment.
Comment: One commenter disagreed with the five categories of scope
equipment that CMS identified and finalized in CY 2017. This commenter
stated that these five categories did not represent all scope equipment
categories and recommended adding a sixth category, a multi-channeled
flexible video scope.
Response: We will take the recommendation from the commenter into
consideration. We look forward to receiving additional feedback from
stakeholders regarding whether adding a sixth category for multi-
channeled flexible video scopes would be appropriate as part of the
project to organize scope equipment.
[[Page 52993]]
Comment: Several commenters stated that some of the scope equipment
currently in use was inaccurately priced, and appeared to reflect older
technology that has become outdated. One commenter submitted an
extensive list of invoices related to the pricing of scope equipment.
Response: We appreciate the submission of additional information
related to scope pricing from the commenters. We stated in the proposed
rule that we anticipated adopting detailed changes to scope systems at
the code level for CY 2019 in order to incorporate additional feedback
from expert stakeholders. Since we did not propose any additional
pricing changes to scope equipment for CY 2018 due to this proposed
reorganization, we believe that it would be more appropriate to delay
any price updates until the following year rather than make changes for
CY 2018 and, again, shortly thereafter. The general reorganization of
scopes taking place in CY 2019 will include updates to scope pricing.
After consideration of comments received, we will not finalize our
proposal to create and price a single scope equipment code for each of
the five categories previously identified. Instead, we are supportive
of the recommendation from the commenters to create scope equipment
codes on a per-specialty basis for these five, or potentially six,
categories of scopes as applicable. Our goal is to create an
administratively simple scheme that will be easier to maintain and
helps to reduce administrative burden. We look forward to receiving
detailed recommendations from expert stakeholders regarding the number
of these scope equipment items that would be typically required for
each scope category as well as the proper pricing for each scope.
We are not finalizing our proposal to add an LED light source and
an increase to the price of the scope video system of $1,000.00 to
cover the expense of miscellaneous small equipment associated. We
intend to address these changes for CY 2019 in order to incorporate the
aforementioned feedback from expert stakeholders.
(4) Clarivein Kit for Mechanochemical Vein Ablation
In the CY 2017 PFS final rule, we finalized work RVUs and direct PE
inputs for two new codes related to mechanochemical vein ablation, CPT
codes 36473 (Endovenous ablation therapy of incompetent vein,
extremity, inclusive of all imaging guidance and monitoring,
percutaneous, mechanochemical; first vein treated) and 36474
(Endovenous ablation therapy of incompetent vein, extremity, inclusive
of all imaging guidance and monitoring, percutaneous, mechanochemical;
subsequent vein(s) treated in a single extremity, each through separate
access sites). Following the publication of the final rule,
stakeholders contacted CMS and requested that a Clarivein kit supply
item (SA122) be added to the direct PE inputs for CPT code 36474, the
add-on code for ablation of subsequent veins. They stated that the
Clarivein kit was accidentally omitted from the RUC recommendations,
and that an additional kit is necessary to perform the service
described by the add-on procedure. We solicited comment regarding the
use of multiple kits during procedures described by the base and add-on
codes to determine whether or not this supply should be included as a
direct PE input for CPT code 36474 for CY 2018.
The following is a summary of the public comments received
regarding the use of the Clarivein kit supply in CPT code 36474 for CY
2018 and our responses:
Comment: A device manufacturer wrote to explain the proper assembly
and use of the Clarivein kit in great detail. The commenter stated that
the kit is used to treat a single vein and a separate Clarivein kit is
necessary for each vein treated to ensure functionality and safety. The
commenter cited an informal survey of their customers which suggested
that more than 50 percent of mechanochemical vein ablation procedures
require treatment of a subsequent vein. The commenter urged that CMS
include the Clarivein kit as a supply input for CPT code 36474.
Response: We appreciate the additional information from the
commenter regarding the use of the Clarivein kit supply.
Comment: Several commenters disagreed with the proposed inclusion
of the Clarivein kit as a supply input for CPT code 36474. A commenter
indicated that a second Clarivein kit might be needed for CPT code
36474 in some cases, but noted that the mechanochemical vein ablation
codes have been flagged as new technology and will be reviewed by the
RUC during the next two years. This commenter recommended that the
number of Clarivein kits necessary for CPT code 36474 should be
reviewed at that time.
Response: We agree with the commenter that the decision on whether
to include a Clarivein kit in CPT code 36474 should be made as part of
a broader review of the direct PE inputs that are typically required to
furnish the procedure. We also note that if physicians do not typically
use the kit when furnishing services described by the add-on codes,
then including the kit as part of the direct PE inputs for the add-on
code would represent a significant misvaluation. After consideration of
comments received, we are not finalizing the addition of the Clarivein
kit to CPT code 36474 at this time, though we will review any
recommendations received for consideration in future rulemaking.
(5) Removal of Oxygen From Non-Moderate Sedation Post-Procedure
Monitoring
After finalizing the creation of separately billable codes for
moderate sedation during the CY 2017 PFS final rule, we received
additional recommendations to remove the oxygen gas supply item (SD084)
from a series of CPT codes that were previously valued with moderate
sedation as an inherent part of the procedure. Because oxygen gas is
included in the moderate sedation pack contained within the separately
billed moderate sedation codes, we believe that the continued inclusion
of the oxygen gas in these codes is a duplicative supply. Therefore, we
proposed to remove the oxygen gas from the codes in Table 5.
Table 5--CY 2018 Proposed Removal of Oxygen (SD084) From Non-Moderate
Sedation Post-Procedure Monitoring
------------------------------------------------------------------------
Current
HCPCS NF/F (liters) Cost
------------------------------------------------------------------------
31622......................... NF 90 -0.27
31625......................... NF 105 -0.32
31626......................... NF 135 -0.41
31627......................... NF 150 -0.45
[[Page 52994]]
31628......................... NF 120 -0.36
31629......................... NF 105 -0.32
31632......................... NF 54 -0.16
31633......................... NF 60 -0.18
31652......................... NF 180 -0.54
31653......................... NF 225 -0.68
31654......................... NF 90 -0.27
52647......................... NF 10 -0.03
52648......................... NF 10 -0.03
90870......................... NF 198 -0.59
------------------------------------------------------------------------
Comment: Several commenters supported our proposal to remove the
oxygen gas for this list of codes.
Response: We appreciate the support for our proposal. After
consideration of the comments, we are finalizing our proposal to remove
the oxygen gas from the codes listed in Table 5.
(6) Technical Corrections to Direct PE Input Database and Supporting
Files
Subsequent to the publication of the CY 2017 PFS final rule,
stakeholders alerted us to several clerical inconsistencies in the
direct PE database. We proposed to correct these inconsistencies as
described in the proposed rule and reflected in the CY 2018 proposed
direct PE input database displayed on the CMS Web site under downloads
for the CY 2018 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
For CY 2018, we proposed to address the following inconsistencies:
For CY 2018, we proposed to make direct PE changes for CPT
code 96416 (Chemotherapy administration, intravenous infusion
technique; initiation of prolonged chemotherapy infusion (more than 8
hours), requiring use of a portable or implantable pump) to improve
payment accuracy, in response to a stakeholder inquiry regarding the
use of the ambulatory IV pump equipment for this service. We proposed
to add 6 additional minutes of RN/OCN clinical labor (L056A), 4 minutes
for the ``Review charts by chemo nurse regarding course of treatment &
obtain chemotherapy-related medical hx'' task, and 2 minutes for the
``Greet patient and provide gowning'' task. We proposed to add 1
quantity of the IV infusion set supply (SC018) and proposed to lower
the quantity from 2 to 1 of the 20 ml syringe supply (SC053). We
proposed to add 1800 minutes for the new ambulatory IV pump equipment,
and we proposed to increase the equipment time of the medical recliner
chair (EF009) from 83 minutes to 89 minutes to match the increase in
RN/OCN clinical labor. For CY 2018, these proposed direct PE changes
would be used to calculate the PE RVU for CPT code 96416. We sought
comments on these proposed direct PE refinements.
We proposed to correct an anomaly in the postservice work
time for CPT code 91200 (Liver elastography, mechanically induced shear
wave (e.g., vibration), without imaging, with interpretation and
report) by changing it from 5 minutes to 3 minutes, which also results
in a refinement in the total work time for the code from 18 minutes to
16 minutes.
In the process of making updates to our direct PE
database, we discovered a series of discrepancies between the finalized
direct PE inputs and the values entered into the database from previous
calendar years. To reconcile these discrepancies, we proposed the
following direct PE refinements:
Table 6--Direct PE Database Data Discrepancies and Proposed Changes
----------------------------------------------------------------------------------------------------------------
Input code
HCPCS Input code description NF/F Old New Cost
----------------------------------------------------------------------------------------------------------------
11307............ SF033............ scalpel with NF 1 2 0.69
blade, surgical
(#10-20).
11311............ SG056............ gauze, sterile NF 1 2 0.80
4in x 4in (10
pack uou).
11311............ SH046............ lidocaine 1% w- NF 10 4 -0.38
epi inj
(Xylocaine w-
epi).
11719............ L037D............ Greet patient, NF 1 3 0.74
provide
gowning, ensure
appropriate
medical records
are available.
11719............ L037D............ Provide pre- NF 1 2 0.37
service
education/
obtain consent.
11719............ L037D............ Prepare room, NF 1 2 0.37
equipment,
supplies.
11719............ L037D............ Clean room/ NF 1 3 0.74
equipment by
physician staff.
17312............ SL097............ OCT Tissue-Tek.. NF 8 6 -0.12
17313............ SF004............ blade, microtome NF 1 0 -1.72
17313............ SF044............ blade, surgical, NF 0 1 4.17
super-sharp.
17313............ SG056............ gauze, sterile NF 3 0 -2.39
4in x 4in (10
pack uou).
17313............ SG088............ tape, foam, NF 10 8 -0.01
elastic, 2in
(Microfoam).
17314............ SG056............ gauze, sterile NF 2 0 -1.60
4in x 4in (10
pack uou).
17314............ SL097............ OCT Tissue-Tek.. NF 8 6 -0.12
17315............ SL078............ histology NF 0 0.2 0.29
freezing spray
(Freeze-It).
19283............ L043A............ Service total NF 55 54 -0.43
costs.
19286............ L051B............ Service total NF 30 31 0.51
costs.
19286............ EL015............ room, NF 19 20 1.40
ultrasound,
general.
19286............ EQ168............ light, exam..... NF 19 20 0.00
23333............ L037D............ Post service F 63 90 9.99
total costs.
28045............ SC029............ needle, 18-27g.. NF 2 1 -0.09
[[Page 52995]]
32405............ L041B............ Service total NF 52 57 2.05
costs.
37765............ L037D............ Service total NF 91 94 1.11
costs.
37766............ L037D............ Service total NF 121 124 1.11
costs.
45171............ SJ052............ swab, procto F 2 3 0.12
16in.
45172............ L037D............ Service total F 6 12 2.22
costs.
45172............ SJ052............ swab, procto F 2 3 0.12
16in.
52214............ SH047............ lidocaine 1%-2% NF 1 50 1.72
inj (Xylocaine).
72120............ EL012............ room, basic NF 16 17 0.48
radiology.
72148............ L047A............ Service total NF 47 49 0.84
costs.
74230............ L041B............ Technologist NF 0 2 0.82
QC's images in
PACS, checking
for all images,
reformats, and
dose page.
91013............ EF023............ table, exam..... NF 0 9 0.03
91013............ EF015............ mayo stand...... NF 0 9 0.01
91013............ EQ235............ suction machine NF 0 9 0.02
(Gomco).
91013............ EQ181............ manometry system NF 0 9 1.15
(computer,
transducers,
catheter).
91013............ EQ339............ manometry NF 0 9 0.05
accessory cable.
91013............ ED050............ PACS Workstation NF 0 9 0.20
Proxy.
91132............ EQ019............ EGG monitoring NF 22 30 0.83
system.
92227............ EL006............ lane, screening NF 12 0 -1.07
(oph).
92227............ EL005............ lane, exam (oph) NF 0 12 1.15
93017............ L051A............ Preservice total NF 15 5 -5.10
costs.
95819............ SG079............ tape, surgical NF 6 42 0.07
paper 1in
(Micropore).
----------------------------------------------------------------------------------------------------------------
The proposed PE RVUs displayed in Addendum B on our Web site were
calculated with the inputs displayed in the CY 2018 proposed direct PE
input database.
The following is a summary of the public comments received on these
proposed direct PE refinements and our responses:
Comment: Several commenters indicated their support for the
proposed direct PE changes for CPT code 96416. Commenters stated that
the proposed changes accurately reflected provider time and intensity
in providing this service and would help to ensure that cancer care and
treatment are appropriately valued and reimbursed. There were no
comments opposed to the proposed changes.
Response: We appreciate the support for our proposal from the
commenters. We are finalizing the direct PE changes to CPT code 96416
as proposed.
Comment: One commenter was uncertain how CMS arrived at the
conclusion that there were discrepancies of the direct PE inputs for
the identified codes in Table 5 of the proposed rule. The commenter
disagreed with several of the proposed changes to the data
discrepancies and requested that CMS clarify the method used to
determine these discrepancies in the direct PE inputs.
Response: Prior to the publication of the CY 2018 proposed rule, we
identified a series of anomalies in our direct PE database where the
entered data did not match the values that had been finalized through
rulemaking. For example, in CY 2013 we finalized the RUC recommendation
to include 1 surgical super-sharp blade (SF044) in CPT code 17313.
However, the direct PE database for CPT code 17313 instead included 1
microtome blade (SF004), which was not included in the finalized PE
inputs at all. This discrepancy was due to a technical issue that
occurred while inputting the values into the database during the CY
2013 rule cycle. The same pattern applies to the other discrepancies in
the data that we identified for the codes on the table above: the
information in the database was discrepant with the direct PE inputs
that had been finalized in previous calendar years. We proposed this
series of changes in order to ensure that the PE inputs in our database
matched the inputs that have been finalized through rulemaking. We did
not propose to make changes in the direct PE inputs of these codes
based on clinical judgment or new recommendations, only to correct the
technical anomalies that had crept into the direct PE database via user
error. As a result, after consideration of comments received, we are
finalizing the proposed changes to the direct PE database detailed in
the previous table.
Comment: One commenter alerted CMS to a series of similar technical
corrections in the Physician Work Time file. The commenter stated that
there was an issue with 108 codes that had incorrect immediate
postservice times and total times that had been identified in the CY
2014 final rule as due to an inadvertent error. The commenter also
stated that in the CY 2014 PFS final rule with comment period physician
work time file, CMS implemented the correct number and level of
postoperative visits and correct total times, though inadvertently kept
erroneously inflated immediate postservice times for these codes. In
addition, the commenter stated that for CY 2015 up to the present, this
erroneous immediate postservice time was added back into the total
time, resulting in the total times being again incorrect for these 100+
services. The commenter submitted additional data for these codes and
requested that CMS implement a technical correction.
Response: After reviewing the data supplied by the commenter, we
agree that these 108 codes contained an erroneous amount of total time.
As the commenter mentioned, we previously addressed these codes in the
CY 2014 PFS final rule with comment period (78 FR 74259) with a
technical correction. We believe this correction will populate the
physician time file with data that, absent the inadvertent error, would
have been present in the time file. We are finalizing a technical
correction to the physician work time of these codes as noted in Table
7.
Table 7--Technical Correction to Physician Work Total Time
------------------------------------------------------------------------
CY 2017 CY 2018
CPT code total time total time
------------------------------------------------------------------------
19368......................................... 830 770
19369......................................... 755 690
20100......................................... 296 266
20816......................................... 809 697
20822......................................... 685 590
20824......................................... 784 690
20827......................................... 728 625
[[Page 52996]]
20838......................................... 1085 986
20955......................................... 1095 957
20969......................................... 1216 1048
20970......................................... 1156 988
20973......................................... 1156 988
21139......................................... 458 466
21151......................................... 715 686
21154......................................... 857 853
21155......................................... 972 939
21188......................................... 570 572
22100......................................... 475 372
22101......................................... 490 387
22110......................................... 595 479
22112......................................... 675 530
22114......................................... 685 530
22210......................................... 763 609
22212......................................... 788 640
22214......................................... 763 624
22220......................................... 733 585
22222......................................... 818 651
22224......................................... 808 666
22315......................................... 315 252
22325......................................... 652 528
22326......................................... 600 480
22327......................................... 723 604
22548......................................... 800 673
22556......................................... 693 557
22590......................................... 630 501
22595......................................... 650 521
22600......................................... 595 490
22610......................................... 656 549
22630......................................... 599 487
22800......................................... 695 571
22802......................................... 670 538
22804......................................... 768 595
22808......................................... 691 530
22810......................................... 751 595
22812......................................... 854 700
32650......................................... 400 290
32656......................................... 517 377
32658......................................... 420 330
32659......................................... 492 357
32661......................................... 400 300
32664......................................... 420 330
32820......................................... 1054 854
33236......................................... 376 346
33237......................................... 516 456
33238......................................... 517 472
33243......................................... 642 537
33321......................................... 949 754
33417......................................... 1003 750
33502......................................... 973 688
33503......................................... 1213 838
33504......................................... 1043 789
33600......................................... 958 628
33602......................................... 928 628
33606......................................... 1058 728
33608......................................... 938 668
33690......................................... 883 636
33702......................................... 956 751
33722......................................... 908 608
33732......................................... 848 578
33735......................................... 1073 770
33736......................................... 848 548
33750......................................... 968 722
33764......................................... 1023 750
33767......................................... 938 608
33774......................................... 1348 998
33788......................................... 1033 736
33802......................................... 751 556
33803......................................... 811 586
33820......................................... 558 414
33824......................................... 811 615
33840......................................... 831 639
33845......................................... 978 726
33851......................................... 891 700
33852......................................... 951 719
33853......................................... 998 668
33917......................................... 878 608
33920......................................... 958 658
33922......................................... 756 546
33974......................................... 464 314
34502......................................... 951 741
35091......................................... 995 790
35694......................................... 546 456
35901......................................... 602 482
35903......................................... 506 416
49422......................................... 212 182
49429......................................... 407 317
50320......................................... 598 524
50845......................................... 823 613
56632......................................... 1013 683
60520......................................... 624 474
60521......................................... 595 445
60522......................................... 703 533
61557......................................... 627 510
63700......................................... 497 401
63702......................................... 567 463
63704......................................... 732 609
63706......................................... 800 679
64712......................................... 245 294
------------------------------------------------------------------------
We note that the technical correction to the total work time of
these codes will not have a direct effect on the calculation of their
individual RVUs, as changes to work time affect code valuation at the
specialty level, not the service level, in the ratesetting methodology.
For additional information, please see section II.B.2.c. of this final
rule regarding the allocation of PE to services.
Comment: In addition to these 108 codes detailed above, the same
commenter identified seven additional codes with a need for potential
technical corrections in their physician work times. Listed in order,
the commenter identified these issues:
For CPT code 28122 (Partial excision (craterization,
saucerization, sequestrectomy, or diaphysectomy) bone (e.g.,
osteomyelitis or bossing); tarsal or metatarsal bone, except talus or
calcaneus), in the CY2012 Final Rule CMS finalized 0.5 99238 discharge
visits. The commenter stated that the CY 2018 Physician Work Time file
incorrectly still listed this service as having one 99238 visit.
For CPT code 46900 (Destruction of lesion(s), anus (e.g.,
condyloma, papilloma, molluscum contagiosum, herpetic vesicle), simple;
chemical), the commenter stated that the CY 2018 Physician Work Time
file inadvertently omitted one 99213 post-operative visit for this 10-
day global service. When this service was last reviewed by the PEAC in
March 2004, the PEAC recommended and CMS finalized 36 minutes of RN/
LPN/MTA post-service period time, which corresponds with one 99213
office visit bundled into the 10-day global period. Therefore, the
commenter stated that the CY 2018 direct PE inputs and the physician
work time file for this service did not match.
For CPT code 47562 (Laparoscopy, surgical;
cholecystectomy), the CY 2013 final rule only detailed refining the
preservice work time and made no mention of not accepting the RUC
recommended postoperative visits. The commenter stated that the work
time file should have two 99213 post-operative visits instead of one.
For CPT code 76948 (Ultrasonic guidance for aspiration of
ova, imaging supervision and interpretation), the commenter stated that
the CY 2014 final rule did not mention any refinements to the RUC-
recommended times for the interim final valuation of this service. For
the CY 2015 final rule, the preamble text discussed removing preservice
and postservice work times for a different service in this family of
codes, CPT code 76945. The commenter stated that it appeared that this
refinement was inadvertently applied to both CPT codes 76948 and 76945
in the work time file.
For CPT code 77767 (Remote afterloading high dose rate
radionuclide skin surface brachytherapy, includes basic dosimetry, when
performed; lesion diameter up to 2.0 cm or 1 channel), the commenter
stated that the CY 2016 NPRM work time file included the RUC-
recommended preservice, intraservice and postservice work times but
incorrectly summed the total time (listed as CPT dummy code number
7778A). The commenter stated that this error appeared to have been
carried forward to the present, since there was no mention of any work
time refinements for this code in the CY 2016 final rule.
For CPT codes (93668 Peripheral arterial disease (PAD)
rehabilitation, per session) and 96904 (Whole body integumentary
photography, for monitoring of high risk patients with dysplastic nevus
syndrome or a history of dysplastic nevi, or patients with a personal
or familial history of melanoma), the RUC had recommended and CMS had
agreed that these services do not include physician work. However, the
commenter stated that the CY 2018 physician work time file
[[Page 52997]]
erroneously listed physician time for these services.
The commenter requested for the work time for these services to be
corrected in the CY 2018 Physician Work Time file for the CY 2018 final
rule.
Response: After reviewing the data supplied by the commenter, we
agree that six of the seven codes identified by the commenter contained
an erroneous amount of work time. We do not agree with the commenter
regarding CPT code 76948, as the refinements to work time that took
place were finalized as intended, and were not due to confusion with
CPT code 76945 (80 FR 70970-70971). For the other six codes, we are
finalizing technical corrections to the work time file as described by
the commenter.
After consideration of comments received, we are finalizing the
direct PE changes to CPT code 96416 as proposed, the correction to an
anomaly in the postservice work time for CPT code 91200 as proposed,
and the proposed changes to the direct PE database detailed in Table 6.
We are also finalizing technical corrections in physician work times as
detailed above in the preceding paragraphs.
(7) Updates to Prices for Existing Direct PE Inputs
In the CY 2011 PFS final rule with comment period (75 FR 73205), we
finalized a process to act on public requests to update equipment and
supply price and equipment useful life inputs through annual
rulemaking, beginning with the CY 2012 PFS proposed rule. For CY 2018,
we proposed the following price updates for existing direct PE inputs.
We proposed to update the price of thirteen supplies and one
equipment item in response to the public submission of invoices. For
the details of these proposed price updates, please refer to section
II.H, of this final rule, Table 16: Invoices Received for Existing
Direct PE Inputs.
We did not propose to update the price of the blood warmer (EQ072),
the cell separator system (EQ084), or the photopheresor system (EQ206)
equipment items. The only pricing information that we received for
these three equipment items was an invoice that included a hand-written
price over redacted information. We were unable to verify the accuracy
of this invoice. We are also not proposing to update the price of the
DNA image analyzer (ACIS) (EP001) equipment item, due to the inclusion
of many components on the submitted invoice that are not part of the
price of the DNA image analyzer. We were unable to determine which of
these components were included in the cost of the DNA image analyzer,
and which of these components were unrelated types of equipment. To
price these equipment items accurately, we believe that we need
additional information. We continued to use the current price for these
equipment items pending the submission of additional pricing
information. We welcomed the submission of updated pricing information
regarding these equipment items through valid invoices from commenters
and other stakeholders.
We also proposed to change the name of the ED050 equipment from the
``PACS Workstation Proxy'' to the ``Technologist PACS workstation.'' In
the CY 2017 final rule (81 FR 80180-80182), we finalized a policy to
add a professional PACS workstation (ED053) to the list of approved
equipment items, and we believe that renaming ED050 to the technologist
PACS workstation would help to alleviate potential confusion between
the two PACS workstations.
We routinely accept public submission of invoices as part of our
process for developing payment rates for new, revised, and potentially
misvalued codes. Often these invoices are submitted in conjunction with
the RUC-recommended values for the codes. For CY 2018, we note that
some stakeholders have submitted invoices for new, revised, or
potentially misvalued codes after the February 10th deadline
established for code valuation recommendations. To be included in a
given year's proposed rule, we generally need to receive invoices by
the same February 10th deadline. However, we would consider invoices
submitted as public comments during the comment period following the
publication of the proposed rule, and would consider any invoices
received after February or outside of the public comment process as
part of our established annual process for requests to update supply
and equipment prices.
The following is a summary of the public comments received on
updates to prices for new and existing direct PE inputs and our
responses:
Comment: Several commenters supported the price changes that CMS
proposed in response to the submission of invoices.
Response: We appreciate the response from the commenters, as well
as the timely submission of these invoices prior to the February 10th
deadline.
Comment: One commenter, in response to the CMS request for
additional updated pricing information for the blood warmer (EQ072),
the cell separator system (EQ084), the photopheresor system (EQ206),
and the DNA image analyzer (EP001) equipment items, submitted an
attachment with current valid invoices. The commenter urged CMS to use
these invoices to update the price of these equipment items.
Response: We appreciate the additional invoices from the commenter
in response to our request for more information in the proposed rule.
We are finalizing updated prices for all four of these equipment items
as detailed in Table 16: Invoices Received for Existing Direct PE
Inputs. For the first three equipment items, we are finalizing the
price indicated on their respective invoices. For the DNA image
analyzer (EP001), we are finalizing a price of $248,946.30, based on
the submitted price of $258,042.30 minus the price of the user training
($6,800.00), the instructor-led online training ($646.00) and the
shipping and handling costs ($1,650.00). These costs are allocated
through the indirect allocation under the established PE methodology.
We are also finalizing a change in the name of the EP001 equipment from
``DNA image analyzer'' to ``DNA/digital image analyzer'' as requested
by commenters.
Comment: Several commenters disagreed with the proposed price of
$4.10 for the UV goggles (SJ027) supply and the proposal to treat the
patient and clinician goggles used for photodynamic therapy as the same
SJ027 supply item rather than create a new supply code. One commenter
stated they were concerned with the blended price methodology used by
CMS to calculate the proposed price, and indicated that the current
market price was higher than the proposed price for the SJ027 supply.
Another commenter stated that the goggles used for photodynamic therapy
are proprietary to the company that produces aminolevulinic acid and
are not available through other sources, which made the use of the
proposed blended price inappropriate. Commenters submitted several
additional invoices for the price of both the UV goggles and the
patient/clinician goggles used for photodynamic therapy.
Response: We appreciate the additional information supplied by the
commenters regarding these different types of goggles, especially the
additional pricing information included in the invoices. After
consideration of the comments, we agree that these are two separate
supply items and that it would not be appropriate to blend their prices
together. We are finalizing a price of $7.95 for the UV goggles (SJ027)
and a price of $6.00 for the new patient/clinician goggles (SD326).
Regarding the
[[Page 52998]]
new SD326 supply, since these very similar goggles were produced by the
same company and sold for the same price, we did not agree that each of
them should be described by a separate supply code and will instead
group them together as ``patient/clinician goggles'' under a single
supply code.
Comment: Several commenters disagreed with the price update to the
LMX 4% anesthetic cream (SH092) supply and the use of an online price
quote found by CMS. A commenter stated that physicians' only purchased
drugs from reputable medical suppliers in order to ensure the safety of
their patients and that the current price of the SH092 supply was
accurate. The commenters also submitted three additional invoices for
the SH092 supply.
Response: We disagree with the commenters that the use of prices
obtained online carries an elevated risk of patient complications due
to false or improperly prepared medication. We have no reason to
believe that healthcare providers will typically purchase medical
supplies and equipment at higher than rates generally available on the
market, and LMX 4% anesthetic cream is a widely available non-
prescription supply item that can be commonly found both online and in
pharmaceutical stores. We have no reason to believe the price quote
that we obtained online is atypical of market rates or reflects an
inferior product that represents a danger to patients. However, given
commenters' suggestions that some physicians purchase the item at
prices higher than the best market price, we will average together our
online price quote together with the three invoices submitted by the
commenters. We are therefore finalizing a price of $1.357 for the SH092
supply based on the use of this methodology.
Comment: One commenter addressed the proposed update to the price
of the INR test strips (SJ055) supply. The commenter stated that the
price change would lead to substantial reductions for HCPCS codes G0248
and G0249, and while the commenter agreed that the market price for INR
test strips had changed since the item was priced initially 15 years
ago, the current direct PE inputs for these codes did not reflect the
resources typically required to furnish the services.
Response: We appreciate the additional information submitted by the
commenter. Although we are finalizing the price of the INR test strip
(SJ055) at the proposed rate of $5.66, we agree that the current direct
PE inputs for these services may not reflect the typical resources that
they require. For additional details regarding the INR Monitoring codes
and refinements to their direct PE inputs, please refer to the code
valuation section (II.H) of this final rule.
Comment: One commenter requested that the cytology, preservative
and vial, (cytospin) 88108--30ml (SL501) supply should be deleted from
the CMS supply database. The commenter stated that this supply is
redundant with the cytology, preservative and vial (Preserv-cyt)
(SL040) supply and that the quantity of SL040 for CPT code 88108 should
be 1 item. The commenter stated that this was an error made in 2014 and
in 2015 when CPT code 88108 code was reviewed and urged CMS to correct
this error.
Response: After reviewing the supply inputs for CPT code 88108, we
agree with the commenter. The SL501 supply appeared in no other CPT
codes and did not have a price. We agree that the resources typically
required to furnish CPT code 88108 are more accurately described by
including 1 quantity of the SL040 supply. We are finalizing this
addition to CPT code 88108 and the removal of the SL501 supply from our
database.
Comment: One commenter called attention to the fact that there are
a number of supply and equipment items that currently do not have a
price. The commenter stated that the lack of a price adversely affects
the specialties when they use these supply and equipment items since
the cost of the item is not being factored into the formula used to
determine the PE RVU. The commenter stated that CMS should ensure that
all supplies and equipment have a price included in the database in
order to facilitate payment for all the resources associated with a
service.
Response: We appreciate the extra attention drawn by the commenter
to the supply and equipment items currently present in our database
that lack a price. We encourage commenters to submit invoices to update
the pricing of these supplies and equipment items through the process
detailed above.
Comment: One commenter stated that CMS provides no additional
payments for drug-coated balloons and bundles those payments within the
payments of existing procedures for office-based procedures. The
commenter indicated that CMS proposed to package the device costs of
drug coated balloons into the costs of the procedures with which the
device is utilized, which meant that angioplasty procedures with drug
coated balloons and plain balloons will receive the same payment
amount. The commenter detailed the clinical benefits of drug coated
balloons in angioplasty and requested an alternate payment structure to
avoid patient access barriers to this technology.
Response: We appreciate the additional information supplied by the
commenter regarding the use of drug coated balloons. We encourage
stakeholders to submit comments with additional information when
practice patterns for services may change over time, which may lead to
the nomination of individual services as potentially misvalued.
However, the commenter did not provide specific CPT codes in which
these new treatments would be utilized, nor did the commenter supply
evidence to indicate that the use of these drug coated balloons would
be typical. We also did not receive recommendations from the RUC or
other medical specialty groups requesting the addition of drug coated
balloons as a new supply item. As a result, we will retain the current
direct PE inputs for angioplasty services unless otherwise mentioned in
this final rule.
Comment: One commenter stated concerns regarding the need for more
accurate pricing of expensive equipment and disposable supplies. The
commenter noted that the current pricing of supplies and equipment,
based on the voluntary submission of small numbers of invoices, creates
the potential for highly biased, non-representative invoices, and makes
these cost inputs relatively unreliable. This potential overestimation
of resource costs augments the reimbursement disparities between
proceduralists and primary care physicians, inappropriately rewards
physicians who perform procedures, and provides an improper incentive
for overuse of these services. The commenter suggested addressing this
issue through subjecting expensive equipment and supplies to fixed
discounting of their costs over time.
Response: We agree with the commenter that the methodology used for
price updates to new and existing supplies and equipment has the
potential to create disparities in resource cost. As we have stated in
past rulemaking, such as in the CY 2016 final rule with comment period
(80 FR 70896), we do not believe that very small numbers of voluntarily
submitted invoices are likely to reflect typical resource costs and
create the potential for overestimation of supply and equipment costs.
As part of our authority under section 1848(c)(2)(M) of the Act to
collect and use information on physicians' services in the
determination of relative values under the PFS, which was added to the
statute by section 220(a)(1) of the PAMA, we
[[Page 52999]]
have initiated a contract to collect data that we hope will facilitate
more accurate prices for supplies and equipment. Based on the data
collected and additional stakeholder feedback, we may make proposals to
update supply and equipment pricing in future rulemaking. We will also
consider other suggestions to address the issues involving high cost
supplies and equipment, such as the fixed discounting recommended by
the commenter.
After consideration of comments received, we are finalizing the
updated supply and equipment prices as detailed in Table 16: Invoices
Received for Existing Direct PE Inputs.
4. Adjustment to Allocation of Indirect PE for Some Office-Based
Services
As we explain in section II.B.2.c.(2) of this final rule, we
allocate indirect costs for each code on the basis of the direct costs
specifically associated with a code and the greater of either the
clinical labor costs or the work RVUs. Indirect expenses include
administrative labor, office expense, and all other expenses. For PFS
services priced in both the facility and non-facility settings, the
difference in indirect PE RVUs between the settings is driven by
differences in direct PE inputs for those settings since the other
allocator of indirect PE, the work RVU, does not differ between
settings. For most services, the direct PE input costs are higher in
the nonfacility setting than in the facility setting. As a result,
indirect PE RVUs allocated to these services are higher in the
nonfacility setting than in the facility setting. When direct PE inputs
for a service are very low, however, the allocation of indirect PE RVUs
is almost exclusively based on work RVUs, which results in a very small
(or no) site of service differential between the total PE RVUs in the
facility and nonfacility setting.
Some stakeholders have suggested that for codes in which direct PE
inputs for a service are very low, this allocation methodology does not
allow for a site of service differential that accurately reflects the
relative indirect costs involved in furnishing services in nonfacility
settings. Among the services most affected by this anomaly are the
primary therapy and counseling services available to Medicare
beneficiaries for treatment of behavioral health conditions, including
substance use disorders. For example, for the most commonly reported
psychotherapy service (CPT code 90834), the difference between the
nonfacility and facility PE RVUs is only 0.02 RVUs, which seems
unlikely to represent the difference in relative resource costs in
terms of administrative labor, office expense, and all other expenses
incurred by the billing practitioner for 45 minutes of psychotherapy
services when furnished in the office setting versus the facility
setting.
We agree with these stakeholders that the site of service
differential for these services that is produced by our PE methodology
seems unlikely to reflect the relative resource costs for the
practitioners furnishing these services in nonfacility settings. For
example, we believe the 0.02 RVUs, which translates to approximately
$0.72, would be unlikely to reflect the relative administrative labor,
office rent, and other overhead involved in furnishing the 45 minute
psychotherapy service in a nonfacility setting. Consequently, we
believe it would be appropriate to modify the existing methodology for
allocating indirect PE RVUs in order to better reflect the relative
indirect PE resources involved in furnishing these kinds of services in
the nonfacility setting.
In examining the range of services furnished in the nonfacility
setting that are most affected by this circumstance, we identified
HCPCS codes that describe face-to-face services, have work RVUs greater
than zero, and are priced in both the facility and nonfacility setting.
From among these codes, we further selected those with the lowest ratio
between nonfacility PE RVUs and work RVUs. We selected 0.4 as an
appropriate threshold based on several factors, including the range of
nonfacility PE RVU to work RVU ratios among the codes identified. Based
on these criteria, there were fewer than 50 codes that we identified
with a ratio of less than 0.4 nonfacility PE RVUs for each work RVU,
most of which are primarily furnished by behavioral health
professionals, for a potential modification to our indirect PE
allocation methodology.
In considering how to address the anomaly and ensure that an
appropriate number of indirect PE RVUs are allocated to these services
in the nonfacility setting, we looked at the indirect, nonfacility PE
RVU for the most commonly billed physician office visit, CPT code
99213, which is billed by a wide range of physicians and non-physician
practitioners under the PFS. We believe that the indirect PE costs
allocated to services reported with CPT code 99213, including
administrative labor and office rent, would be common for a broad range
of physicians and non-physician practitioners across the PFS. We
recognize that the services we seek to address are primarily furnished
by behavioral health professionals who may be unlikely to incur some of
the costs incurred by other practitioners furnishing a broader range of
medical services. For instance, a practitioner furnishing a broader
range of primary care services likely requires separate office and
examination room space, and storage for disposable medical supplies and
equipment. Some costs, however, such as those for office staff and
records maintenance, would be analogous.
We looked at the relationship between indirect PE and work RVUs for
CPT code 99213 as a marker because that is the most commonly and
broadly reported PFS code that describes face-to-face office-based
services. We compared the relationship between indirect PE and work
RVUs for the set of HCPCS codes that we identified using the criteria
discussed above and found that for the significant majority of codes,
that ratio was at least 0.4 nonfacility PE RVUs for each work RVU. We
believe the 0.4 nonfacility PE RVUs can serve as an appropriate marker
that appropriately reflects the relative resources involved in
furnishing these services.
For the fewer than 50 outlier codes identified using the criteria
above, we believe it would be appropriate to establish a minimum
nonfacility indirect PE RVU that would be a better reflection the
resources involved in furnishing these services. We propose to set the
nonfacility indirect PE RVUs for these codes using the indirect PE RVU
to work RVU ratio for the most commonly furnished office-based, face-
to-face service (CPT 99213) as a marker. Specifically, for each of
these outlier codes, we propose to compare the ratio between indirect
PE RVUs and work RVUs that result from the preliminary application of
the standard methodology to the ratio for the marker code, CPT code
99213. Our proposed change in the methodology would then increase the
allocation of indirect PE RVUs to the outlier codes to at least one
quarter of the difference between the two ratios. We believe this
approach reflects a reasonable minimum allocation of indirect PE RVUs,
but we do not currently have empirical data that would be useful in
establishing a more precise number.
In developing the proposed PE RVUs for CY 2018, we proposed to
implement only one quarter of this proposed minimum value for
nonfacility indirect PE for the outlier codes. We recognize that this
change in the PE methodology could have a significant impact on the
allocation of indirect PE RVUs across all PFS services. In making
significant changes to the PE methodology in
[[Page 53000]]
previous years, we have implemented such changes using 4 year
transitions, based largely on concerns that some specialties experience
significant payment reductions with changes in PE relativity, and a
transition period allows for a more gradual adjustment for affected
practitioners. Under the approach we proposed, we estimate that
approximately $40 million, or approximately 0.04 percent of total PFS
allowed charges, would shift within the PE methodology for each year of
the proposed 4-year transition, including for CY 2018. We also note
that we proposed to exclude the codes directly subject to this proposed
change from the misvalued code target calculation because the proposed
change is a methodological change to address an anomaly produced by our
indirect PE allocation process as opposed to a change to address
misvalued codes. The PE RVUs displayed in Addendum B on our Web site
were calculated with the one quarter of the indirect PE adjustment
factor implemented.
The following is a summary of the public comments received on our
proposed change to the indirect PE methodology for some office-based
services.
Comment: Several commenters supported the CMS proposal. Commenters
stated that the proposal would more accurately reflect the resource
costs incurred by psychiatrists providing services for patients with
mental health and substance use disorders in nonfacility settings. One
commenter indicated their support for the commitment of greater
resources toward behavioral and mental health services given the
ongoing opioid crisis. Commenters were also supportive of the proposal
to exclude the codes directly impacted by this change in methodology
from the misvalued code target.
Response: We appreciate the support from the commenters for our
proposal.
Comment: One commenter disagreed with the CMS proposal. The
commenter stated that this change to PE methodology could have a
significant impact on the allocation of indirect PE RVUs across all PFS
services, with approximately 0.04 percent of the total PFS allowed
charges shifting within the PE methodology. The commenter recommended
that the proposal should not be finalized until it was discussed
through the RUC process, and that the codes in question should be
placed on the misvalued code list.
Response: We appreciate the feedback from the commenter on our
proposal. We note that the RUC has generally provided recommendations
on a routine basis regarding work, work time, and direct PE inputs. We
do not believe that placing these codes on the misvalued code list for
additional RUC review would serve to address the issues identified in
our proposal, as we do not have reason to believe that the work or
direct PE inputs assigned to these services are inaccurate. However, we
welcome recommendations from the RUC or other interested stakeholders
on any aspects of the PFS ratesetting methodology, including elements
that have not traditionally been provided such as indirect PE
allocation. We believe that CMS receiving public input on potential
changes to the methodology is critical and that notice and comment
rulemaking is the best way to obtain such input. We do not agree that
changes in the methodology need to be developed or discussed as part of
the RUC process prior to being implemented through notice and comment
rulemaking.
After consideration of comments received, we are finalizing our
proposed change to the indirect PE methodology for some office-based
services.
C. Determination of Malpractice Relative Value Units (RVUs)
1. Overview
Section 1848(c) of the Act requires that each service paid under
the PFS be composed of three components: Work, PE, and malpractice (MP)
expense. As required by section 1848(c)(2)(C)(iii) of the Act,
beginning in CY 2000, MP RVUs are resource based. Section
1848(c)(2)(B)(i) of the Act also requires that we review, and if
necessary adjust, RVUs no less often than every 5 years. In the CY 2015
PFS final rule with comment period, we implemented the third review and
update of MP RVUs. For a comprehensive discussion of the third review
and update of MP RVUs see the CY 2015 proposed rule (79 FR 40349
through 40355) and final rule with comment period (79 FR 67591 through
67596).
To determine MP RVUs for individual PFS services, our MP
methodology is composed of three factors: (1) Specialty-level risk
factors derived from data on specialty-specific MP premiums incurred by
practitioners, (2) service level risk factors derived from Medicare
claims data of the weighted average risk factors of the specialties
that furnish each service, and (3) an intensity/complexity of service
adjustment to the service level risk factor based on either the higher
of the work RVU or clinical labor RVU. Prior to CY 2016, MP RVUs were
only updated once every 5 years, except in the case of new and revised
codes.
As explained in the CY 2011 PFS final rule with comment period (75
FR 73208), MP RVUs for new and revised codes effective before the next
5-year review of MP RVUs were determined either by a direct crosswalk
from a similar source code or by a modified crosswalk to account for
differences in work RVUs between the new/revised code and the source
code. For the modified crosswalk approach, we adjusted (or scaled) the
MP RVU for the new/revised code to reflect the difference in work RVU
between the source code and the new/revised work RVU (or, if greater,
the difference in the clinical labor portion of the fully implemented
PE RVU) for the new code. For example, if the proposed work RVU for a
revised code was 10 percent higher than the work RVU for its source
code, the MP RVU for the revised code would be increased by 10 percent
over the source code MP RVU. Under this approach, the same risk factor
was applied for the new/revised code and source code, but the work RVU
for the new/revised code was used to adjust the MP RVUs for risk.
In the CY 2016 PFS final rule with comment period (80 FR 70906
through 70910), we finalized a policy to begin conducting annual MP RVU
updates to reflect changes in the mix of practitioners providing
services (using Medicare claims data), and to adjust MP RVUs for risk,
intensity and complexity (using the work RVU or clinical labor RVU). We
also finalized a policy to modify the specialty mix assignment
methodology (for both MP and PE RVU calculations) to use an average of
the 3 most recent years of data instead of a single year of data. Under
this approach, for new and revised codes, we generally assign a
specialty risk factor to individual codes based on the same utilization
assumptions we make regarding the specialty mix we use for calculating
PE RVUs and for PFS budget neutrality. We continue to use the work RVU
or clinical labor RVU to adjust the MP RVU for each code for intensity
and complexity. In finalizing this policy, we stated that the
specialty-specific risk factors would continue to be updated through
notice and comment rulemaking every 5 years using updated premium data,
but would remain unchanged between the 5-year reviews.
In CY 2017, we finalized the eighth GPCI update, which reflected
updated MP premium data. We did not propose to use the updated MP
premium data to propose updates for CY 2017 to the specialty risk
factors used in the calculation of MP RVUs because it was inconsistent
with the policy we previously finalized in the CY 2016 PFS
[[Page 53001]]
final rule with comment period, whereby we indicated that the
specialty-specific risk factors would continue to be updated through
notice and comment rulemaking every 5 years using updated premium data,
but would remain unchanged between the 5-year reviews. However, we
solicited comment on whether we should consider doing so, perhaps as
early as for CY 2018, prior to the fourth review and update of MP RVUs
that must occur no later than CY 2020. After consideration of the
comments received, we stated that we would consider the possibility of
using the updated MP data to update the specialty risk factors used in
the calculation of the MP RVUs prior to the next 5-year update in
future rulemaking (81 FR 80191 through 80192). Since MP premium data
are used to update both the MP GPCIs and the MP RVUs, going forward we
believe it would be logical to align the update of MP premium data used
to determine the MP RVUs with the update of the MP GPCI. Section
1848(e)(1)(C) of the Act requires us to review and, if necessary,
adjust the GPCIs at least every 3 years. The next review of the GPCIs
must occur by CY 2020.
In the CY 2018 PFS proposed rule, we proposed to use the most
recent data for the MP RVUs for CY 2018 and to align the update of MP
premium data and MP GPCIs to once every 3 years. We sought comment on
these proposals, and we also sought comment on methodologies and
sources that we might use to improve the next update of MP premium
data.
2. Methodology for the Revision of Resource Based Malpractice RVUs
a. General Discussion
The proposed MP RVUs were calculated based on updated malpractice
premium data obtained from state insurance rate filings by a CMS
contractor. The methodology used in calculating the proposed CY 2018
review and update of resource based MP RVUs largely paralleled the
process used in the CY 2015 update. The calculation requires using
information on specialty-specific malpractice premiums linked to
specific services based upon the relative risk factors of the various
specialties that furnish a particular service. Because malpractice
premiums vary by state and specialty, the malpractice premium
information must be weighted geographically and by specialty.
Accordingly, the proposed MP RVUs were based upon four data sources: CY
2014 and CY 2015 malpractice premium data; CY 2016 and 2017 Medicare
payment and utilization data; CY 2017 GPCIs, and CY 2018 proposed work
and clinical labor RVUs.
Similar to the previous update, we calculated the proposed MP RVUs
using specialty-specific malpractice premium data because they
represent the actual expense incurred by practitioners to obtain
malpractice insurance. We obtained malpractice premium data exclusively
from the most recently available data published in the 2014 and 2015
Market Share Reports accessed from the National Association of
Insurance Commissioners (NAIC) Web site. We used information obtained
from malpractice insurance rate filings with effective dates in 2014
and 2015. These were the most current data available during our data
collection process.
We collected malpractice insurance premium data from all 50 States,
the District of Columbia, and Puerto Rico. Rate filings were not
available in American Samoa, Guam or the Virgin Islands. Premiums were
for $1 million/$3 million, mature, claims-made policies (policies
covering claims made, rather than those covering services furnished,
during the policy term). A $1 million/$3 million liability limit policy
means that the most that would be paid on any claim is $1 million and
the most that the policy would pay for claims over the timeframe of the
policy is $3 million. We made adjustments to the premium data to
reflect mandatory surcharges for patient compensation funds (funds to
pay for any claim beyond the statutory amount, thereby limiting an
individual physician's liability in cases of a large suit) in states
where participation in such funds is mandatory.
We included premium information for all physician and NPP
specialties, and all risk classifications available in the collected
rate filings. Although we collected premium data from all states, the
District of Columbia, and Puerto Rico, not all specialties had distinct
premium data in the rate filings from all states. Additionally, for
some specialties, MP premiums were not available from the rate filings
in any state. Therefore, for specialties for which there were not
premium data for at least 35 states, and specialties for which there
were not distinct premium data in the rate filings, we crosswalked the
specialty to a similar specialty, either conceptually or by available
premium data, for which we did have sufficient and reliable data.
For example, for radiation oncology, data were only available from
23 states, and therefore this specialty does not meet our 35-state
threshold, which determines whether or not a specialty is deemed to
have premium data sufficient to construct a unique risk factor.
However, based on the 23 states' worth of rate filings for radiation
oncology, the resource costs for the premiums suggests a similar,
though slightly lesser average than that of the premiums for diagnostic
radiology. We developed the proposed MP RVUs for radiation oncology by
crosswalking the risk factor for diagnostic radiology as a similar
specialty with similar premium data. We sought comment as to the
appropriateness of this and the other crosswalks used in developing MP
RVUs.
For the proposed CY 2018 MP RVU update, sufficient and reliable
premium data were available for 43 specialty types, representing over
76 percent of allowed Medicare PFS services, which we used to develop
specialty specific malpractice risk factors.
b. Steps for Calculating Malpractice RVUs
Calculation of the proposed MP RVUs conceptually follows the
specialty-weighted approach used in the CY 2015 final rule with comment
period (79 FR 67591). The specialty-weighted approach bases the MP RVUs
for a given service upon a weighted average of the risk factors of all
specialties furnishing the service. This approach ensures that all
specialties furnishing a given service are accounted for in the
calculation of the MP RVUs. The steps for calculating the proposed MP
RVUs are described below.
Step (1): Compute a preliminary national average premium for each
specialty.
Insurance rating area malpractice premiums for each specialty are
mapped to the county level. The specialty premium for each county is
then multiplied by its share of the total U.S. population (from the
U.S. Census Bureau's 2014 American Community Survey (ACS) estimates).
This is in contrast to the method used for creating national average
premiums for each specialty in the 2015 update; in that update,
specialty premiums were weighted by the total RVU per county, rather
than by the county share of the total U.S. population. We refer readers
to the CY 2016 PFS final rule with comment period (80 FR 70909) for a
discussion of why we have adopted a weighting method based on a share
of the total U.S. population. This calculation is then divided by the
average MP GPCI across all counties for each specialty to yield a
normalized national average premium for each specialty. The specialty
premiums are normalized for geographic variation so that the locality
cost differences (as
[[Page 53002]]
reflected by the GPCIs) would not be counted twice. Without the
geographic variation adjustment, the cost differences among fee
schedule areas would be reflected once under the methodology used to
calculate the MP RVUs and again when computing the service specific
payment amount for a given fee schedule area.
Step (2): Determine which premium class(es) to use within each
specialty.
Some specialties had premium rates that differed for surgery,
surgery with obstetrics, and non-surgery. These premium classes are
designed to reflect differences in risk of professional liability and
the cost of malpractice claims if they occur. To account for the
presence of different classes in the malpractice premium data and the
task of mapping these premiums to procedures, we calculated distinct
risk factors for surgical, surgical with obstetrics, and nonsurgical
procedures. However, the availability of data by surgery and non-
surgery varied across specialties. Consistent with the CY 2015 MP RVU
update, because no single approach accurately addressed the variability
in premium class among specialties, we employed several methods for
calculating average premiums by specialty. These methods are discussed
below.
(a) Substantial Data for Each Class: For 10 out of 86 specialties,
we determined that there were sufficient data for surgery and non-
surgery premiums, as well as sufficient differences in rates between
classes. Therefore, we calculated a national average surgical premium
and non-surgical premium. We noted that, unlike in the CY 2015 MP RVU
update, for CY 2018, there were no specialties that fell under the
``unspecified dominates'' specialty/surgery class scenario; therefore,
we omitted that surgical class category.
(b) Major Surgery Dominates: For 9 surgical specialties, rate
filings that included non-surgical premiums were relatively rare. For
most of these surgical specialties, the rate filing did not include an
``unspecified'' premium. When it did, the unspecified premium was lower
than the major surgery rate. For these surgical specialties, we
calculated only a surgical premium and used the premium for major
surgery for all procedures furnished by this specialty.
(c) Blend All Available: For the remaining specialties, there was
wide variation across the rate filings in terms of whether or not
premium classes were reported and which categories were reported.
Because there was no clear strategy for these remaining specialties, we
blended the available rate information into one general premium rate.
For these specialties, we developed a weighted average ``blended''
premium at the national level, according to the percentage of work RVUs
correlated with the premium classes within each specialty. For example,
the surgical premiums for a given specialty were weighted by that
specialty's work RVUs for surgical services; the nonsurgical premiums
were weighted by the work RVUs for non-surgical services and the
unspecified premiums were weighted by all work RVUs for the specialty
type.
Step (3): Calculate a risk factor for each specialty.
The relative differences in national average premiums between
specialties are expressed in our methodology as a specialty risk
factor. These risk factors are an index calculated by dividing the
national average premium for each specialty by the national average
premium for the specialty with the lowest premiums for which we had
sufficient and reliable data, allergy and immunology. For specialties
with sufficient surgical and non-surgical premium data, we calculated
both a surgical and non-surgical risk factor. For specialties with rate
filings that distinguished surgical premiums with obstetrics, we
calculated a separate surgical with obstetrics risk factor. For all
other specialties, we calculated a single risk factor and applied the
specialty risk factor to both surgery and non-surgery services.
We noted that for determining the risk factor for suppliers of TC-
only services in the CY 2015 update, we updated the premium data for
independent diagnostic testing facilities (IDTFs) that we used in the
CY 2010 update. These data were obtained from a survey conducted by the
Radiology Business Management Association (RBMA) in 2009; we ultimately
used these data to calculate an updated TC specialty risk factor. We
applied the updated TC specialty risk factor to suppliers of TC-only
services. In the CY 2015 final rule with comment period (79 FR 67595),
RBMA voluntarily submitted updated MP premium information collected
from independent diagnostic testing facilities (IDTFs) in 2014, and
requested that we use the data for calculating the CY 2015 MP RVUs for
TC services. We declined to utilize the data and stated that we believe
further study is necessary and we would consider this matter and
propose any changes through future rulemaking. We believed that data
for a broader set of technical component services are needed, and
sought comment on appropriate, comparable data sources for such
information. We also sought comment on whether the data for IDTFs are
comparable and appropriate as a proxy for the broader set of TC
services. We endeavor to, in the next update of specialty risk factors,
collect more data across a broader set of the technical component
services, not just for radiology (as is currently reflected in the RBMA
data), but data for services performed by other non-physician
practitioners including cytotechnologists, and cardiovascular
technologists. In the interim, for CY 2018, we proposed to assign a TC
risk factor of 1.0, which corresponds to the lowest physician specialty
risk factor.
We assigned the risk factor of 1.0 to the TC services because we
did not have comparable professional liability premium data for the
full range of clinicians that furnish these services. In lieu of
comprehensive, comparable data, we used 1.0 as the default minimum risk
factor, though we sought information on the best available data sources
for use in the next update, as well as empirical information that would
support assignment of an alternative risk factor for these services.
Step (4): Calculate malpractice RVUs for each HCPCS code.
Resource-based MP RVUs were calculated for each HCPCS code that has
work or PE RVUs. The first step was to identify the percentage of
services furnished by each specialty for each respective HCPCS code.
This percentage was then multiplied by each respective specialty's risk
factor as calculated in Step 3. The products for all specialties for
the HCPCS code were then added together, yielding a specialty-weighted
service specific risk factor reflecting the weighted malpractice costs
across all specialties furnishing that procedure. The service specific
risk factor was multiplied by the greater of the work RVU or PE
clinical labor index for that service to reflect differences in the
complexity and risk-of-service between services.
Low volume service codes: As we discussed in section II.B. of this
final rule, we proposed to use a list of expected specialties instead
of the claims-based specialty mix for low volume services in order to
address stakeholder concerns about the year to year variability in PE
and MP RVUs for low volume services. We solicited comments on the
proposal to use these service-level overrides to determine the
specialty for low volume procedures, as well as on the list of
overrides itself.
The proposed list of codes and expected specialties is available on
our Web site under downloads for the CY 2018 PFS proposed rule at
http://www.cms.gov/Medicare/Medicare-Fee-
[[Page 53003]]
for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-
Notices.html. In previous MP RVU updates, as discussed in the CY 2015
final rule with comment period (79 FR 40354), we assigned specialty for
low volume services based on dominant specialty. As discussed in the CY
2012 final rule with comment period (76 FR 73187 through 73189), we
applied an additional list of service-level overrides for purposes of
calculating MP RVUs for a number of cardiothoracic surgery codes.
Therefore, we noted that there are certain codes for which we have
previously applied expected specialty overrides for purposes of
calculating MP RVUs based on assumptions regarding low Medicare volume.
Because we are consolidating policies for low volume service expected
specialty overrides into a single list for PE and MP, and because we
did not believe that there is a reason to assume different specialties
for purposes of calculating PE RVUs than for MP RVUs for any particular
code, we also proposed to assign the specialty mix solely based on the
claims data for any code that does not meet the low volume threshold of
99 allowed services or fewer in the previous year, for the purposes of
calculating MP RVUs.
Given that we now annually recalibrate MP RVUs based on claims
data, and in light of our proposed introduction of the service-level
specialty override for low volume services, we believed that there
would no longer be a need to apply service-level MP crosswalks in order
to assign a specialty-mix risk factor. Contingent on finalizing this
proposal, we also proposed to eliminate general use of an MP-specific
specialty-mix crosswalk for new and revised codes. However, we would
continue to consider, in conjunction with annual recommendations,
specific recommendations from the public and the RUC regarding
specialty mix assignments for new and revised codes, particularly in
cases where coding changes are expected to result in differential
reporting of services by specialty, or where the new or revised code is
expected to be low-volume. Absent such information, we would derive the
specialty mix assumption for the first year for a new or revised code
from the specialty mix used for purposes of ratesetting. In subsequent
years when claims data are available, we would assign the specialty
based on claims data unless the service does not exceed the low volume
threshold (99 or fewer allowed services). If the service is low volume,
we would assign the expected specialty, establishing a new expected
specialty through rulemaking as needed, which is consistent with our
approach for developing PE RVUs.
Step (5): Rescale for budget neutrality.
The statute requires that changes to fee schedule RVUs must be
budget neutral. Thus, the last step is to adjust for relativity by
rescaling the proposed MP RVUs so that the total proposed resource
based MP RVUs are equal to the total current resource based MP RVUs
scaled by the ratio of current aggregate MP and work RVUs. This scaling
is necessary in order to maintain the work RVUs for individual services
from year to year while also maintaining the overall relationship among
work, PE, and MP RVUs.
Additional information on our proposed methodology for updating the
MP RVUs may be found in our contractor's report, ``Interim Report on
Malpractice RVUs for the CY 2018 PFS Proposed Rule,'' which is
available on the CMS Web site under the downloads section of the CY
2018 PFS proposed rule located at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
We sought comments on these proposals for calculating the MP RVUs
for CY 2018. The following is a summary of the public comments received
on our proposals and our responses:
Comment: Several commenters, including the RUC, expressed concerns
about the proposed valuation changes, which they believe were not
indicative of what is occurring in the professional liability premium
market. The RUC stated that, generally, the market has not reflected
significant changes in the past several years. The commenters stated
that the premium data collected for this update were insufficient, and
many noted changes in specialty premiums and risk factors compared to
the last update as particularly concerning. Some commenters expressed
concern that CMS was unable to obtain sufficient data from all states
for common specialties and questioned the validity of the data being
used to propose new MP RVUs for CY 2018. The RUC stated that while the
crosswalks proposed by CMS appear to be appropriate, they were
concerned with the data collection process, and recommended that rather
than crosswalking, CMS should acquire adequate premium data. Several
commenters, including the RUC, specifically expressed concern about the
proposed Cardiology surgical risk factor. The commenters disagreed with
the risk factor for Cardiology being classified as a blend rather than
split into distinct surgical and non-surgical risk factors as it had
been in the past, and recommended that CMS use the Cardiac Surgery Risk
Factor as a more appropriate crosswalk to establish a Cardiology
surgical risk factor or otherwise maintain the existing risk factors
while additional data are gathered. Several commenters, including the
RUC, stated that CMS should consider delaying implementation of new
premium data until CMS has the opportunity to seek additional data to
avoid blending risk factors and crosswalking. While some commenters
were generally supportive of more frequent updates of MP premium data
and aligning updates of MP RVUs with the triennial MP GPCI updates,
they stated that given concerns about accuracy and flaws in the
methodology for calculating MP risk factors, that CMS should not
accelerate the schedule for updating MP RVUs based on the MP GPCI data
at this time. A few commenters recommended that CMS not modify the
current 5-year cycle of updating the MP premium data used in the MP RVU
calculations to every 3 years; one commenter stated that more frequent
updates will cause greater variation in the MP RVU calculations.
Response: We agree that some of the changes are substantial
compared to the last update and merit further consideration. However,
we believe it is important to delineate the precise cause of these
changes, as the shifts were primarily driven by changes in how the rate
filings were classified by specialty, rather than inherent deficiencies
in the raw rate filing data. We collected malpractice premium data from
the NAIC's System for Electronic Rate and Form Filing (SERFF) Access
Interface, which is a standardized data source that includes many rate
filings from the same insurers that were used in the CY 2015 MP RVU
update, as well as additional data. Using SERFF enabled us to collect
malpractice data for 32 states. For states that do not participate in
the SERFF Access Interface, we contacted state departments of insurance
and requested medical malpractice rate filings. Using these methods, we
were able to collect a total of 7,212 raw rate filings from all 50
states, the District of Columbia, and Puerto Rico. This is an
improvement on the CY 2015 update, for which 3,473 raw rate filings
were collected. We note that the number of specialties with sufficient
data in this proposed update is very similar to prior years. In the CY
2010 update, sufficient data were found for 44 specialties. In the CY
2015 update, sufficient data were found for 41 specialties, and we
found sufficient
[[Page 53004]]
data for 43 specialties in the proposed CY 2018 update. Overall, there
is very little change in the total number of specialties with
sufficient data.
For the the comments that noted differences in which specialties
had sufficient data this year, compared to the CY 2015 update, we have
determined that this is due to differences in the codes that insurance
issuers use to identify the physician speciality on the descriptions on
the raw rate filings and/or how these raw data were categorized into
CMS specialties. CMS specialty coding information is not available on
the raw rate filings, and Insurance Services Office (ISO) codes are
only sometimes present. Thus, it is always necessary to use a crosswalk
to map malpractice premium data to the CMS specialty classifications.
This means that changes in malpractice insurers' premium coding
practices or the rate filing categorization process can easily lead to
shifts in the number of rate filings across related specialties, which
in turn may skew the weighting of the data, which is what we observed
in the CY 2018 proposed update.
The Cardiology specialty is illustrative of this issue. In the last
update, Cardiology had a surgical risk factor of 6.98 and a non-
surgical risk factor of 1.93. In this update, Cardiology did not have
sufficient data to compute separate surgical and non-surgical risk
factors and was proposed to receive a blended risk factor of 1.90. This
change was understandably concerning to several commenters. The reason
that Cardiology did not have sufficient data to compute a surgical risk
factor was directly due to how the raw rate filings were categorized
rather than the data availability itself. In the past, some rate
filings that referred to cardiac surgery and interventional cardiology
in their specialty descriptions were categorized as Specialty 06:
Cardiology, but comparable filings for this year's proposal were
categorized as Specialty 78: Cardiac Surgery and C3: Interventional
Cardiology. As several commenters suggested, it is possible to mitigate
this problem by assigning Cardiology to receive the surgical risk
factor of Cardiac Surgery. In the long-term, we understand commenters'
concerns and in order to alleviate this issue, we intend to revisit how
we categorize all rate filings by specialty. This is particularly
important because some physicians may not have updated their specialty
codes despite performing surgical and interventional cardiac
procedures, and we want to ensure that their rates are properly
adjusted if they are still registered as part of the general Cardiology
specialty. We also understand that this issue may have occurred for
other groups of related specialties and intend to do a comprehensive
assessment in the future to avoid potential discrepancies such as those
previously described. For these reasons, we are not finalizing our
proposal to use the most recent data for the CY 2018 MP RVUs and to
align the update of MP premium data and MP GPCIs to once every 3 years.
We recognize that, going forward, we need to resolve differences
regarding the variances in the descriptions on the raw rate filings as
well as how these raw data were categorized to conform with the CMS
specialties.
Comment: One commenter expressed concern that the average premiums
and risk factors for Interventional Cardiology were not proposed. The
Interventional Cardiology specialty code went into effect in January
2015, so the commenter urged CMS to establish risk factors for this
specialty.
Response: Because the malpractice rate filings collected for this
update were from 2014 and 2015, very little data were available for
Interventional Cardiology. Until more data are available, it will be
necessary to crosswalk this specialty to receive average premiums and
risk factors from cardiac specialties that carry similar levels of
risk.
Comment: A few commenters expressed concern about a lack of
transparency in the proposed changes to the determination of MP RVUs,
and some stated that stakeholders were at a disadvantage and unable to
respond to the changes and assumptions used in the proposed update to
MP RVUs.
Response: We would like to note that the methodology as well as the
steps for calculating MP RVUs were outlined in the preamble text to the
proposed rule, and are also included in this final rule; we sought
comments on these proposals in the proposed rule. The documentation
included in the Downloads section on the CMS Web site support and
provide additional technical details and information used in
establishing the proposed policies. To the extent that the supporting
documentation is material to the proposals we made in the proposed
rule, we believe they are within the scope of the rule. Information
that provides more context and understanding of the data, and how the
data is collected, which can be found in the contractor's report, is
material to the rulemaking process, so when stakeholders provide
concerns about the supporting documentation we consider those concerns
as comments in response to the proposals. We also note that this has
been our longstanding process.
Comment: Several commenters, including the RUC, stated that CMS
should not crosswalk non-physician specialties to the lowest physician
risk factor specialty for which it has premium rates, which is Allergy
Immunology. The commenters stated that CMS should collect premium data
for the non-physician specialties or otherwise use the data from the
AMA's Physician Practice Expense Information Survey from 2006. The
commenters expressed that this crosswalk would likely serve as an
overestimate of professional liability for non-physician specialties.
Response: We thank commenters for their feedback, and would like to
clarify that we did collect whatever data was available for non-
physician specialties during our data collection process. This enabled
us to find sufficient data for one major non-physician specialty--Nurse
Practitioner, which received a blended risk factor of 1.95.
Additionally, we note that not all non-physician specialties were
mapped to Allergy/Immunology. For example, Certified Nurse Midwife was
mapped to Obstetrics and Gynecology, and Certified Registered Nurse
Anesthesiologist was mapped to Anesthesiology, which both reflect
higher risk than Allergy/Immunology. We revisited the malpractice rate
filings we collected for other non-physician specialties, and although
they did not meet the 35-state threshold for sufficient data to compute
specialty premiums and risk factors, some of the data we do have
indicate premiums and risk factors that are close to that of Allergy/
Immunology. Therefore, we believe that the proposed crosswalks were
reasonable. However, we are not finalizing our proposal.
Comment: One commenter highlighted that the Sleep Medicine
specialty did not have sufficient data in this proposed update and was
crosswalked to General Practice, which the commenter did not believe
was appropriate.
Response: We appreciate the commenter's feedback, and note that
this is the same crosswalk that was used in the last update.
Additionally, while the surgical risk factor decreases for General
Practice in the proposed update, the non-surgical factor increased. We
revisited the malpractice rate filings we collected for Sleep Medicine
and, although they did not meet the 35-state threshold for sufficient
data to compute specialty premiums and risk factors, the data we do
have indicate premiums and risk factors that are close to that of
General Practice.
[[Page 53005]]
Therefore, we believe that the proposed crosswalk was reasonable.
However, we are not finalizing our proposal.
Comment: A few specialty societies expressed support for the
proposed crosswalks as an appropriate course of action given the lack
of available data for most non-physician specialties. One commenter
expressed concern that insufficient data was found for Hospice and
Palliative Care and it was mapped to Allergy/Immunology. Another
commenter expressed support for crosswalking Certified Registered Nurse
Anesthesiologist (CRNA) to Anesthesiology, though they question whether
Anesthesiology Assistant should have been crosswalked the same way.
Response: We appreciate the commenters' feedback and support. We
reviewed the malpractice rate filings that were collected for Hospice
and Palliative Care, and although they did not meet the 35-state
threshold for sufficient data to compute specialty premiums and risk
factors, the data we do have indicate premiums and risk factors that
are close to Allergy/Immunology; we also note that insufficient data
for this specialty were found in the last update and it was previously
crosswalked to Allergy/Immunology. We also reviewed the malpractice
rate filings that were collected for Anesthesiology Assistant and
similarly, although they did not meet the threshold for sufficient
data, the data we do have indicate premium and risk factors that are
close to that of Anesthesiology. Therefore, we believe that the
proposed crosswalks were reasonable. However, we are not finalizing our
proposal.
Comment: A few commenters, including the RUC, questioned whether
the 35-state threshold for rate filing data was too high, and suggested
that fewer specialties would need to be crosswalked to receive premiums
and risk factors from other specialties if that requirement were
lowered or removed.
Response: While we agree that lowering the threshold would allow
more specialties to receive dedicated premiums and risk factors, we
believe that lowering the 35 state threshold would have a direct trade-
off with the accuracy and the reliability of the results. Removing or
lowering the threshold would increase the likelihood that the resulting
premiums and risk factors could fluctuate due to outliers.
Additionally, the 35-state threshold is consistent with the past
updates to MP RVUs.
Comment: A few commenters urged CMS to use work RVUs instead of
regional population counts to weight geographic differences to
calculate national average premiums.
Response: We thank the commenters for their feedback, and note this
population weighting refinement to the MP RVU methodology was issued
through notice and comment rulemaking in the CY 2016 PFS final rule
with comment period (80 FR 70909 through 70910), and there were no
additional proposals with regard to this matter for CY 2018.
Comment: One commenter recommended that CMS use the phrase ``Family
Medicine'' rather than ``Family Practice'' on the basis that the latter
is considered outdated.
Response: We appreciate the commenter's feedback. We did not
propose changes to the specialty nomenclature; however, we will
consider this in future updates.
Comment: A commenter requested that we add HCPCS codes 92992 and
92993 to the list of invasive cardiology procedures classified as
surgery for purposes of assigning service level risk factors because
cardiac catheterization and angioplasty procedures are similar to
surgical procedures for the purpose of establishing MP premium rates
and risk factors.
Response: HCPCS codes 92992 and 92993 are contractor-priced codes,
for which the Medicare Administrative Contractors (MACs) establish RVUs
and payment amounts. Therefore, we are not adding HCPCS codes 92992 and
92993 to the ``Invasive Cardiology Outside of Surgical Range'' list.
Comment: Several commenters, including the RUC, were supportive of
the proposal to override claims data for low volume services with an
expected specialty for both the PE RVU, and MP RVU valuation process.
The commenters also recommended that CMS use the expected specialty
overrides lists for codes with no Medicare volume for a given year, as
well as low volume codes.
Response: We thank commenters for their support. We refer
commenters to section II.B. of this final rule for further discussion
of low volume service codes.
After consideration of the comments received, we are not finalizing
our proposal to use the most recent data for the CY 2018 MP RVUs and to
align the update of MP premium data and MP GPCIs to once every 3 years.
Similar to CY 2017, the CY 2018 MP RVUs will continue to be based on
the premium data that was collected for the CY 2015 MP RVU update. For
CY 2018, the MP RVUs will be calculated based on the existing specialty
risk factors (the same risk factors that were used to calculate the CY
2017 MP RVUs); these specialty risk factors are shown in the CY 2018
Final Rule Malpractice Risk Factors and Premium Amounts by Specialty
file located on the CMS Web site under the downloads section of the CY
2018 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
For low volume service codes, we thank the commenters for their
support, and we are finalizing the proposal to use a list of expected
specialties, instead of a claims-based specialty mix, for low volume,
which also includes no volume codes, and to apply these overrides for
both PE and MP. We believe that this will simplify the implementation
of service-level overrides for PE and MP, and will also address
stakeholder concerns about year-to-year variability for low volume
services. We refer readers to section II.B. of this final rule for
further discussion regarding the low volume service codes.
We note that the next MP update must occur by CY 2020. We continue
to believe that updating the MP premium data on a more frequent basis
would enable the resulting premiums and RVUs to better reflect market
trends in malpractice insurance for different specialties. In
principle, more frequent updates are optimal, and we will consider this
in future rulemaking.
Many of the commenters expressed concerns regarding the sufficiency
of the data. As previously explained, this is not a matter of a lack of
sufficient or robust data, but an issue regarding how the rate filings
are being classified by specialty. We re-examined the data and after
further review, we recognize that going forward we need to resolve
differences regarding variances in the descriptions on the raw rate
filings as well as how these raw data were categorized to conform with
the CMS specialties. Understanding that this is a driver of the
fluctuations that were reflected in the updated MP RVUs that we
proposed, moving forward we will be able to prioritize reconciling the
coding changes and categorizations in the raw rate filings in order to
avoid data fluctuations between updates that are not representative of
the actual data. We thank the commenters for their detailed feedback,
and will continue to take it into consideration as we work to make the
MP RVUs as accurate as possible for all specialties. We also note that
a few commenters noted concerns regarding potential errors in the
proposed MP RVUs for specific codes as a result of the proposed updated
specialty risk factors; however, since we are not finalizing those MP
RVUs based on the proposed updated specialty risk
[[Page 53006]]
factors, we are not responding to those comments in this final rule.
The resource based MP RVUs for CY 2018 are shown in Addendum B,
which is available on the CMS Web site under the downloads section of
the CY 2018 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
C. Medicare Telehealth Services
1. Billing and Payment for Telehealth Services
Several conditions must be met for Medicare to make payments for
telehealth services under the PFS. The service must be on the list of
Medicare telehealth services and meet all of the following additional
requirements:
The service must be furnished via an interactive
telecommunications system.
The service must be furnished by a physician or other
authorized practitioner.
The service must be furnished to an eligible telehealth
individual.
The individual receiving the service must be located in a
telehealth originating site.
When all of these conditions are met, Medicare pays a facility fee
to the originating site and makes a separate payment to the distant
site practitioner furnishing the service.
Section 1834(m)(4)(F)(i) of the Act defines Medicare telehealth
services to include professional consultations, office visits, office
psychiatry services, and any additional service specified by the
Secretary, when furnished via a telecommunications system. We first
implemented this statutory provision, which was effective October 1,
2001, in the CY 2002 PFS final rule with comment period (66 FR 55246).
We established a process for annual updates to the list of Medicare
telehealth services as required by section 1834(m)(4)(F)(ii) of the Act
in the CY 2003 PFS final rule with comment period (67 FR 79988).
As specified at Sec. 410.78(b), we generally require that a
telehealth service be furnished via an interactive telecommunications
system. Under Sec. 410.78(a)(3), an interactive telecommunications
system is defined as multimedia communications equipment that includes,
at a minimum, audio and video equipment permitting two-way, real-time
interactive communication between the patient and distant site
physician or practitioner.
Telephones, facsimile machines, and stand-alone electronic mail
systems do not meet the definition of an interactive telecommunications
system. An interactive telecommunications system is generally required
as a condition of payment; however, section 1834(m)(1) of the Act
allows the use of asynchronous ``store-and-forward'' technology when
the originating site is part of a federal telemedicine demonstration
program in Alaska or Hawaii. As specified in Sec. 410.78(a)(1),
asynchronous store-and-forward is the transmission of medical
information from an originating site for review by the distant site
physician or practitioner at a later time.
Medicare telehealth services may be furnished to an eligible
telehealth individual notwithstanding the fact that the practitioner
furnishing the telehealth service is not at the same location as the
beneficiary. An eligible telehealth individual is an individual
enrolled under Part B who receives a telehealth service furnished at a
telehealth originating site.
Practitioners furnishing Medicare telehealth services are reminded
that these services are subject to the same non-discrimination laws as
other services, including the effective communication requirements for
persons with disabilities of section 504 of the Rehabilitation Act of
1973 and section 1557 of the Affordable Care Act, as well as and
language access for persons with limited English proficiency, as
required under Title VI of the Civil Rights Act of 1964 and section
1557 of the Affordable Care Act. For more information, see http://www.hhs.gov/ocr/civilrights/resources/specialtopics/hospitalcommunication.
Practitioners furnishing Medicare telehealth services submit claims
for telehealth services to the Medicare Administrative Contractors
(MACs) that process claims for the service area where their distant
site is located. Section 1834(m)(2)(A) of the Act requires that a
practitioner who furnishes a telehealth service to an eligible
telehealth individual be paid an amount equal to the amount that the
practitioner would have been paid if the service had been furnished
without the use of a telecommunications system.
Originating sites, which can be one of several types of sites
specified in the statute where an eligible telehealth individual is
located at the time the service is being furnished via a
telecommunications system, are paid a facility fee under the PFS for
each Medicare telehealth service. The statute specifies both the types
of entities that can serve as originating sites and the geographic
qualifications for originating sites. For geographic qualifications,
our regulation at Sec. 410.78(b)(4) limits originating sites to those
located in rural health professional shortage areas (HPSAs) or in a
county that is not included in a metropolitan statistical area (MSA).
Historically, we have defined rural HPSAs to be those located
outside of MSAs. Effective January 1, 2014, we modified the regulations
regarding originating sites to define rural HPSAs as those located in
rural census tracts as determined by the Federal Office of Rural Health
Policy of the Health Resources and Services Administration (HRSA) (78
FR 74811). Defining ``rural'' to include geographic areas located in
rural census tracts within MSAs allows for broader inclusion of sites
within HPSAs as telehealth originating sites. Adopting the more precise
definition of ``rural'' for this purpose expands access to health care
services for Medicare beneficiaries located in rural areas. HRSA has
developed a Web site tool to provide assistance to potential
originating sites to determine their geographic status. To access this
tool, see our Web site at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
An entity participating in a federal telemedicine demonstration
project that has been approved by, or received funding from, the
Secretary as of December 31, 2000 is eligible to be an originating site
regardless of its geographic location.
Effective January 1, 2014, we also changed our policy so that
geographic status for an originating site would be established and
maintained on an annual basis, consistent with other telehealth payment
policies (78 FR 74400). Geographic status for Medicare telehealth
originating sites for each calendar year is now based upon the status
of the area as of December 31 of the prior calendar year.
For a detailed history of telehealth payment policy, see 78 FR
74399.
2. Adding Services to the List of Medicare Telehealth Services
As noted previously, in the CY 2003 PFS final rule with comment
period (67 FR 79988), we established a process for adding services to
or deleting services from the list of Medicare telehealth services.
This process provides the public with an ongoing opportunity to submit
requests for adding services, which are then reviewed by us. Under this
process, we assign any submitted request to make additions to the list
of telehealth services to one of two categories. Revisions to the
criteria that we use to review requests in the second category were
finalized in the CY 2012
[[Page 53007]]
PFS final rule with comment period (76 FR 73102). The two categories
are:
Category 1: Services that are similar to professional
consultations, office visits, and office psychiatry services that are
currently on the list of telehealth services. In reviewing these
requests, we look for similarities between the requested and existing
telehealth services for the roles of, and interactions among, the
beneficiary, the physician (or other practitioner) at the distant site
and, if necessary, the telepresenter, a practitioner who is present
with the beneficiary in the originating site. We also look for
similarities in the telecommunications system used to deliver the
service; for example, the use of interactive audio and video equipment.
Category 2: Services that are not similar to the current
list of telehealth services. Our review of these requests includes an
assessment of whether the service is accurately described by the
corresponding code when furnished via telehealth and whether the use of
a telecommunications system to furnish the service produces
demonstrated clinical benefit to the patient. Submitted evidence should
include both a description of relevant clinical studies that
demonstrate the service furnished by telehealth to a Medicare
beneficiary improves the diagnosis or treatment of an illness or injury
or improves the functioning of a malformed body part, including dates
and findings, and a list and copies of published peer reviewed articles
relevant to the service when furnished via telehealth. Our evidentiary
standard of clinical benefit does not include minor or incidental
benefits.
Some examples of clinical benefit include the following:
Ability to diagnose a medical condition in a patient
population without access to clinically appropriate in-person
diagnostic services.
Treatment option for a patient population without access
to clinically appropriate in-person treatment options.
Reduced rate of complications.
Decreased rate of subsequent diagnostic or therapeutic
interventions (for example, due to reduced rate of recurrence of the
disease process).
Decreased number of future hospitalizations or physician
visits.
More rapid beneficial resolution of the disease process
treatment.
Decreased pain, bleeding, or other quantifiable symptom.
Reduced recovery time.
The list of telehealth services, including the proposed additions
described below, is included in the Downloads section to this final
rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
Requests to add services to the list of Medicare telehealth
services must be submitted and received no later than December 31 of
each calendar year to be considered for the next rulemaking cycle. To
be considered during PFS rulemaking for CY 2019, qualifying requests
must be submitted and received by December 31, 2017. Each request to
add a service to the list of Medicare telehealth services must include
any supporting documentation the requester wishes us to consider as we
review the request. Because we use the annual PFS rulemaking process as
a vehicle for making changes to the list of Medicare telehealth
services, requesters should be advised that any information submitted
is subject to public disclosure for this purpose. For more information
on submitting a request for an addition to the list of Medicare
telehealth services, including where to mail these requests, see our
Web site at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
3. Submitted Requests To Add Services to the List of Telehealth
Services for CY 2018
Under our existing policy, we add services to the telehealth list
on a category 1 basis when we determine that they are similar to
services on the existing telehealth list for the roles of, and
interactions among, the beneficiary, physician (or other practitioner)
at the distant site and, if necessary, the telepresenter. As we stated
in the CY 2012 PFS final rule with comment period (76 FR 73098), we
believe that the category 1 criteria not only streamline our review
process for publicly requested services that fall into this category,
but also expedite our ability to identify codes for the telehealth list
that resemble those services already on this list.
We received several requests in CY 2016 to add various services as
Medicare telehealth services effective for CY 2018. The following
presents a discussion of these requests, and our proposals for
additions to the CY 2018 telehealth list. Of the requests received, we
found that three services were sufficiently similar to services
currently on the telehealth list to qualify on a category 1 basis.
Therefore, we proposed to add the following services to the telehealth
list on a category 1 basis for CY 2018:
HCPCS code G0296 (Counseling visit to discuss need for lung
cancer screening using low dose ct scan (ldct) (service is for
eligibility determination and shared decision making))
We found that the service described by HCPCS code G0296 is
sufficiently similar to office visits currently on the telehealth list.
We believed that all the components of this service, which include
assessment of the patient's risk for lung cancer, shared decision
making, and counseling on the risks and benefits of LDCT, can be
furnished via interactive telecommunications technology.
CPT codes 90839 and 90840 (Psychotherapy for crisis; first 60
minutes) and (Psychotherapy for crisis; each additional 30 minutes
(List separately in addition to code for primary service))
We proposed to add CPT codes 90839 and 90840 on a Category 1 basis.
We found that these services are sufficiently similar to the
psychotherapy services currently on the telehealth list, even though
these codes describe patients requiring more urgent care and
psychotherapeutic interventions to minimize the potential for
psychological trauma. However, we identified one specific element of
the services as described in the CPT prefatory language that we
concluded may or may not be able to be furnished via telehealth,
depending on the circumstances of the particular service. The CPT
prefatory language specifies that the treatment described by these
codes requires, ``mobilization of resources to defuse the crisis and
restore safety.'' In many cases, we believed that a distant site
practitioner would have access (via telecommunication technology,
presumably) to the resources at the originating site that would allow
for the kind of mobilization required to restore safety. However, we
also believed that it would be possible that a distant site
practitioner would not have access to such resources. Therefore we
proposed to add the codes to the telehealth list with the explicit
condition of payment that the distant site practitioner be able to
mobilize resources at the originating site to defuse the crisis and
restore safety, when applicable, when the codes are furnished via
telehealth. ``Mobilization of resources'' is a description used in the
CPT prefatory language. We believed the critical element of
``mobilizing resources'' is the ability to communicate with and inform
staff at the originating site to the extent necessary to restore
safety. We solicited comment on whether our assumption that the remote
practitioner is able to mobilize resources at the originating site
[[Page 53008]]
to defuse the crisis and restore safety is valid.
Although we did not receive specific requests, we also proposed to
add four additional services to the telehealth list based on our review
of services. All four of these codes are add-on codes that describe
additional elements of services currently on the telehealth list and
would only be considered telehealth services when billed as an add-on
to codes already on the telehealth list. The four codes are:
CPT code 90785 (Interactive complexity (List separately in
addition to the code for primary procedure))
CPT codes 96160 and 96161 (Administration of patient-focused
health risk assessment instrument (e.g., health hazard appraisal) with
scoring and documentation, per standardized instrument) and
(Administration of caregiver-focused health risk assessment instrument
(e.g., depression inventory) for the benefit of the patient, with
scoring and documentation, per standardized instrument))
HCPCS code G0506 (Comprehensive assessment of and care
planning for patients requiring chronic care management services (list
separately in addition to primary monthly care management service))
In the case of CPT codes 96160 and 96161, and HCPCS code G0506, we
recognized that these services may not necessarily be ordinarily
furnished in-person with a physician or billing practitioner.
Ordinarily, services that are typically not considered to be face-to-
face services do not need to be on the list of Medicare telehealth
services; however, these services would only be considered Medicare
telehealth services when billed with a base code that is also on the
telehealth list and would not be considered Medicare telehealth
services when billed with codes not on the Medicare telehealth list. We
believed that by adding these services to the telehealth list it will
be administratively easier for practitioners who report these services
in association with a visit code that is furnished via telehealth as
both the base code and the add-on code would be reported with the
telehealth place of service.
We also received requests to add services to the telehealth list
that do not meet our criteria for Medicare telehealth services. We did
not propose adding the following procedures for physical, occupational,
and speech therapy, initial hospital care, and online E/M by physician/
qualified healthcare professional to the telehealth list, or changing
the requirements for ESRD procedure codes furnished via telehealth, for
the reasons noted in the paragraphs that follow.
a. Physical and Occupational Therapy and Speech-Language Pathology
Services: CPT Codes--
CPT code 97001: Now deleted and reported with CPT codes 97161,
97162, or 97163, as follows: CPT code 97161 (Physical therapy
evaluation: Low complexity, requiring these components: A history with
no personal factors and/or comorbidities that impact the plan of care;
An examination of body system(s) using standardized tests and measures
addressing 1-2 elements from any of the following: Body structures and
functions, activity limitations, and/or participation restrictions; A
clinical presentation with stable and/or uncomplicated characteristics;
and Clinical decision making of low complexity using standardized
patient assessment instrument and/or measurable assessment of
functional outcome); CPT code 97162 (Physical therapy evaluation:
Moderate complexity, requiring these components: A history of present
problem with 1-2 personal factors and/or comorbidities that impact the
plan of care; An examination of body systems using standardized tests
and measures in addressing a total of 3 or more elements from any of
the following: Body structures and functions, activity limitations,
and/or participation restrictions; An evolving clinical presentation
with changing characteristics; and Clinical decision making of moderate
complexity using standardized patient assessment instrument and/or
measurable assessment of functional outcome); or CPT code 97163
(Physical therapy evaluation: High complexity, requiring these
components: A history of present problem with 3 or more personal
factors and/or comorbidities that impact the plan of care; An
examination of body systems using standardized tests and measures
addressing a total of 4 or more elements from any of the following:
Body structures and functions, activity limitations, and/or
participation restrictions; A clinical presentation with unstable and
unpredictable characteristics; and Clinical decision making of high
complexity using standardized patient assessment instrument and/or
measurable assessment of functional outcome.)
CPT code 97002: Now deleted and reported as CPT code 97164
(Re-evaluation of physical therapy established plan of care, requiring
these components: An examination including a review of history and use
of standardized tests and measures is required; and Revised plan of
care using a standardized patient assessment instrument and/or
measurable assessment of functional outcome.)
CPT code 97003: Now deleted and reported with CPT codes 97165,
97166, or 97167, as follows: CPT code 97165 (Occupational therapy
evaluation, low complexity, requiring these components: An occupational
profile and medical and therapy history, which includes a brief history
including review of medical and/or therapy records relating to the
presenting problem; An assessment(s) that identifies 1-3 performance
deficits (i.e., relating to physical, cognitive, or psychosocial
skills) that result in activity limitations and/or participation
restrictions; and Clinical decision making of low complexity, which
includes an analysis of the occupational profile, analysis of data from
problem-focused assessment(s), and consideration of a limited number of
treatment options. Patient presents with no comorbidities that affect
occupational performance. Modification of tasks or assistance (e.g.,
physical or verbal) with assessment(s) is not necessary to enable
completion of evaluation component); CPT code 97166 (Occupational
therapy evaluation, moderate complexity, requiring these components: An
occupational profile and medical and therapy history, which includes an
expanded review of medical and/or therapy records and additional review
of physical, cognitive, or psychosocial history related to current
functional performance; An assessment(s) that identifies 3-5
performance deficits (i.e., relating to physical, cognitive, or
psychosocial skills) that result in activity limitations and/or
participation restrictions; and Clinical decision making of moderate
analytic complexity, which includes an analysis of the occupational
profile, analysis of data from detailed assessment(s), and
consideration of several treatment options. Patient may present with
comorbidities that affect occupational performance. Minimal to moderate
modification of tasks or assistance (e.g., physical or verbal) with
assessment(s) is necessary to enable patient to complete evaluation
component)); or CPT code 97167 (Occupational therapy evaluation,
[[Page 53009]]
high complexity, requiring these components: An occupational profile
and medical and therapy history, which includes review of medical and/
or therapy records and extensive additional review of physical,
cognitive, or psychosocial history related to current functional
performance; An assessment(s) that identifies 5 or more performance
deficits (i.e., relating to physical, cognitive, or psychosocial
skills) that result in activity limitations and/or participation
restrictions; and Clinical decision making of high analytic complexity,
which includes an analysis of the patient profile, analysis of data
from comprehensive assessment(s), and consideration of multiple
treatment options. Patient presents with comorbidities that affect
occupational performance. Significant modification of tasks or
assistance (e.g., physical or verbal) with assessment(s) is necessary
to enable patient to complete evaluation component.)
CPT code 97004: Now deleted and reported as CPT code 97168
(Re-evaluation of occupational therapy established plan of care,
requiring these components: An assessment of changes in patient
functional or medical status with revised plan of care; An update to
the initial occupational profile to reflect changes in condition or
environment that affect future interventions and/or goals; and a
revised plan of care. A formal reevaluation is performed when there is
a documented change in functional status or a significant change to the
plan of care is required.)
CPT code 97110 (Therapeutic procedure, 1 or more areas, each
15 minutes; therapeutic exercises to develop strength and endurance,
range of motion and flexibility)
CPT code 97112 (Therapeutic procedure, 1 or more areas, each
15 minutes; neuromuscular reeducation of movement, balance,
coordination, kinesthetic sense, posture, and/or proprioception for
sitting and/or standing activities)
CPT code 97116 (Therapeutic procedure, 1 or more areas, each
15 minutes; gait training (includes stair climbing))
CPT code 97535 (Self-care/home management training (e.g.,
activities of daily living (ADL) and compensatory training, meal
preparation, safety procedures, and instructions in use of assistive
technology devices/adaptive equipment) direct one-on-one contact, each
15 minutes)
CPT code 97750 (Physical performance test or measurement
(e.g., musculoskeletal, functional capacity), with written report, each
15 minutes)
CPT code 97755 (Assistive technology assessment (e.g., to
restore, augment or compensate for existing function, optimize
functional tasks and/or maximize environmental accessibility), direct
one-on-one contact, with written report, each 15 minutes)
CPT code 97760 (Orthotic(s) management and training (including
assessment and fitting when not otherwise reported), upper
extremity(s), lower extremity(s) and/or trunk, each 15 minutes)
CPT code 97761 (Prosthetic training, upper and/or lower
extremity(s), each 15 minutes)
CPT code 97762 (Checkout for orthotic/prosthetic use,
established patient, each 15 minutes)
Section 1834(m)(4)(E) of the Act specifies the types of
practitioners who may furnish and bill for Medicare telehealth services
as those practitioners under section 1842(b)(18)(C) of the Act.
Physical therapists, occupational therapists and speech-language
pathologists are not among the practitioners identified in section
1842(b)(18)(C) of the Act. We stated in the CY 2017 PFS final rule (81
FR 80198) that because these services are predominantly furnished by
physical therapists, occupational therapists and speech-language
pathologists, we did not believe it would be appropriate to add them to
the list of telehealth services at this time. In a subsequent
submission for 2018, the original requester suggested that we might
propose these services to be added to the list so that they can be
furnished via telehealth when furnished by eligible distant site
practitioners. We considered that possibility; however, since the
majority of the codes are furnished by therapy professionals over 90
percent of the time, we believed that adding therapy services to the
telehealth list that explicitly describe the services of the kinds of
professionals not included on the statutory list of distant site
practitioners could result in confusion about who is authorized to
furnish and bill for these services when furnished via telehealth. We
also noted that several of these services, such as CPT code 97761,
require directly physically manipulating the beneficiary, which is not
possible to do through telecommunications technology. Therefore, we did
not propose adding these codes to the list of Medicare telehealth
services.
b. Initial Hospital Care Services: CPT Codes--
CPT code 99221 (Initial hospital care, per day, for the
evaluation and management of a patient, which requires these 3 key
components: A detailed or comprehensive history; A detailed or
comprehensive examination; and Medical decision making that is
straightforward or of low complexity. Counseling and/or coordination of
care with other physicians, other qualified health care professionals,
or agencies are provided consistent with the nature of the problem(s)
and the patient's and/or family's needs. Usually, the problem(s)
requiring admission are of low severity.)
CPT code 99222 (Initial hospital care, per day, for the
evaluation and management of a patient, which requires these 3 key
components: A comprehensive history; A comprehensive examination; and
Medical decision making of moderate complexity. Counseling and/or
coordination of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and/or family's needs. Usually, the
problem(s) requiring admission are of moderate severity.)
CPT code 99223 (Initial hospital care, per day, for the
evaluation and management of a patient, which requires these 3 key
components: A comprehensive history; A comprehensive examination; and
Medical decision making of high complexity. Counseling and/or
coordination of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and/or family's needs. Usually, the
problem(s) requiring admission are of high severity.)
We previously considered a request to add these codes to the
telehealth list. As we stated in the CY 2011 PFS final rule with
comment period (75 FR 73315), while initial inpatient consultation
services are currently on the list of approved telehealth services,
there are no services on the current list of telehealth services that
resemble initial hospital care for an acutely ill patient by the
admitting practitioner who has ongoing responsibility for the patient's
treatment during the course of the hospital stay. Therefore, consistent
with prior rulemaking, we did not propose that initial hospital care
services be
[[Page 53010]]
added to the Medicare telehealth services list on a category 1 basis.
The initial hospital care codes describe the first visit of the
hospitalized patient by the admitting practitioner who may or may not
have seen the patient in the decision-making phase regarding
hospitalization. Based on the description of the services for these
codes, we believed it is critical that the initial hospital visit by
the admitting practitioner be conducted in person to ensure that the
practitioner with ongoing treatment responsibility comprehensively
assesses the patient's condition upon admission to the hospital through
a thorough in-person examination. Additionally, the requester submitted
no additional research or evidence that the use of a telecommunications
system to furnish the service produces demonstrated clinical benefit to
the patient; therefore, we also did not propose adding initial hospital
care services to the Medicare telehealth services list on a category 2
basis.
We note that Medicare beneficiaries who are being treated in the
hospital setting can receive reasonable and necessary E/M services
using other HCPCS codes that are currently on the Medicare telehealth
list including those for subsequent hospital care, initial and follow-
up telehealth inpatient and emergency department consultations, as well
as initial and follow-up critical care telehealth consultations.
Therefore, we did not propose to add the initial hospital care
services to the list of Medicare telehealth services for CY 2018.
c. Online E/M by physician/QHP: CPT Code--
CPT code 99444 (Online evaluation and management service
provided by a physician or other qualified health care professional who
may report evaluation and management services provided to an
established patient or guardian, not originating from a related E/M
service provided within the previous 7 days, using the Internet or
similar electronic communications network)
As we indicated in the CY 2016 final rule with comment period (80
FR 71061), CPT code 99444 is assigned a status indicator of ``N'' (Non-
covered service). Under section 1834(m)(2)(A) of the Act, Medicare pays
the physician or practitioner furnishing a telehealth service an amount
equal to the amount that would have been paid if the service was
furnished without the use of a telecommunications system. Because CPT
code 99444 is currently non-covered, there would be no Medicare payment
if this service were furnished without the use of a telecommunications
system. Because this code is a non-covered service for which no
Medicare payment may be made under the PFS, we did not propose adding
online E/M services to the list of Medicare telehealth services for CY
2018.
d. Monthly Capitation Payment (MCP) for ESRD-Related Services for
Home Dialysis, by Age: CPT Codes--
CPT codes 90963 (End-stage renal disease (ESRD) related
services for home dialysis per full month, for patients younger than 2
years of age to include monitoring for the adequacy of nutrition,
assessment of growth and development, and counseling of parents); 90964
(End-stage renal disease (ESRD) related services for home dialysis per
full month, for patients 2-11 years of age to include monitoring for
the adequacy of nutrition, assessment of growth and development, and
counseling of parents); 90965 (End-stage renal disease (ESRD) related
services for home dialysis per full month, for patients 12-19 years of
age to include monitoring for the adequacy of nutrition, assessment of
growth and development, and counseling of parents); and 90966 (End-
stage renal disease (ESRD) related services for home dialysis per full
month, for patients 20 years of age and older)
90967 (End-stage renal disease (ESRD) related services for
dialysis less than a full month of service, per day; for patients
younger than 2 years of age); 90968 (End-stage renal disease (ESRD)
related services for dialysis less than a full month of service, per
day; for patients 2-11 years of age); and 90969 (End-stage renal
disease (ESRD) related services for dialysis less than a full month of
service, per day; for patients 12-19 years of age); and 90970 (End-
stage renal disease (ESRD) related services for dialysis less than a
full month of service, per day; for patients 20 years of age and
older).
In the CY 2004 PFS final rule with comment period (68 FR 63216), we
established HCPCS G-codes for ESRD monthly capitation payments (MCPs),
which were replaced by CPT codes in CY 2009 (73 FR 69898). The services
described by CPT codes 90963 through 90966 were added to the Medicare
telehealth list in CY 2005 (69 FR 66276) and CPT codes 90967 through
90970 were added to the Medicare telehealth list in the CY 2017 PFS
final rule (81 FR 80194); however, we specified that the required
clinical examination of the vascular access site must be furnished
face-to-face ``hands on'' (without the use of an interactive
telecommunications system) by a physician, clinical nurse specialist
(CNS), nurse practitioner (NP), or physician assistant (PA). The
American Telemedicine Association (ATA) submitted a new request for CY
2018 requesting that we allow telehealth coverage of ESRD procedure
codes without in-person exam of the catheter access site monthly. Our
current policy reflects our understanding that evaluation of the
integrity and functionality of the access site is a critical element of
the services described by the codes and that this element cannot be
performed via telecommunications technology. The requester did not
submit evidence to support the assertion that effective examination of
the access site can be executed via telecommunications technology.
Therefore, for CY 2018, we did not propose any changes to the policy
requiring that the MCP practitioner must furnish at least one face-to-
face encounter with the home dialysis patient per month for clinical
examination of the catheter access site. However, we are interested in
more information about current clinically accepted care practices and
to what extent telecommunications technology can be used to examine the
access site. We are also interested in information about the clinical
standards of care regarding the frequency of the evaluation of the
access site.
In summary, we proposed adding the following codes to the list of
Medicare telehealth services beginning in CY 2018 on a category 1
basis:
HCPCS code G0296 (Counseling visit to discuss need for lung
cancer screening using low dose CT scan (ldct) (service is for
eligibility determination and shared decision making))
HCPCS code G0506 (Comprehensive assessment of and care
planning for patients requiring chronic care management services (list
separately in addition to primary monthly care management service))
CPT code 90785 (Interactive complexity (List separately in
addition to the code for primary procedure))
CPT codes 90839 and 90840 (Psychotherapy for crisis; first 60
minutes) and (Psychotherapy for crisis; each additional 30 minutes
(List separately in addition to code for primary procedure))
CPT codes 96160 and 96161 (Administration of patient-focused
health risk assessment instrument
[[Page 53011]]
(e.g., health hazard appraisal) with scoring and documentation, per
standardized instrument) and (Administration of caregiver-focused
health risk assessment instrument (e.g., depression inventory) for the
benefit of the patient, with scoring and documentation, per
standardized instrument)
The following is a summary of the comments we received regarding
the proposed addition of services to the list of Medicare telehealth
services:
Comment: Many commenters supported one or more of our proposals to
add the counseling visit to discuss need for lung cancer screening
using low dose CT scan (LDCT) (HCPCS code G0296) and psychotherapy for
crisis (CPT codes 90839 and 90840) to the Medicare telehealth list for
CY 2018. Commenters also supported one or more of our proposals to add
comprehensive assessment of and care planning for patients requiring
chronic care management services (HCPCS code G0506), interactive
complexity (CPT code 90785) and administration of health risk
assessment (CPT codes 96160 and 96161). Commenters noted that by adding
these services to the Medicare telehealth list, CMS was enhancing
access and quality of care for Medicare beneficiaries.
Response: We thank commenters for their support of the proposed
additions to the list of Medicare telehealth services. After
consideration of the public comments received, we are finalizing our
proposal to add these services to the list of Medicare telehealth
services for CY 2018 on a Category 1 basis.
Comment: Several commenters were supportive of CMS's proposed
requirement that the distant site practitioner be able to mobilize
resources at the originating site to defuse the crisis and restore
safety, when applicable, when furnishing psychotherapy for crisis. One
commenter stated that CMS' requirements for mobilization of resources
are very important and the distant site practitioner should be aware of
available services where the beneficiary is located in the event of a
crisis. Another commenter pointed out that social workers who provide
telehealth services are required by the National Association of Social
Workers to be familiar with the resources in the state in which the
patient resides. Several commenters requested that CMS clarify what was
meant by ``mobilization of resources'' and provide applicable examples.
Response: We appreciate commenters' responses to the explicit
requirement regarding mobilization of resources for the psychotherapy
for crisis codes (CPT codes 90839 and 90840). As noted above,
``mobilization of resources'' is a description used in the CPT
prefatory language. We would reiterate that, according to CPT, the
critical element of ``mobilizing resources'' is the ability to
communicate with and inform staff at the originating site to the extent
necessary to restore safety.
Comment: Several commenters disagreed with the proposal not to add
CPT codes 99221-99223 (inpatient hospital care) to the Medicare
telehealth list. One commenter stated that they believe these services
could be furnished via Medicare telehealth. They pointed to the fact
that for CY 2017, CMS valued the critical care consultation G-codes
(HCPCS codes G0508 and G0509) with RVUs similar to those for the
inpatient hospital care codes as evidence that CMS believes they are
essentially the same service.
Response: As we discussed in the 2018 PFS proposed rule, we do not
believe that the full range of services described by CPT codes 99221-
99223 can be furnished via telecommunications technology as we believe
it is critical that the initial hospital visit by the admitting
practitioner be conducted in person to ensure that the practitioner
with ongoing treatment responsibility comprehensively assesses the
patient's condition upon admission to the hospital through a thorough
in-person examination.
We believe that the telehealth critical care consultation codes
(HCPCS codes G0508 and G0509) more accurately describe the kind of
services that can be furnished to patients via telehealth than the
initial inpatient hospital visit E/M codes that describe services with
elements that can only be furnished in-person. The valuation for HCPCS
codes G0508 and G0509 was developed based on our assessment that the
overall work (resources in time and intensity) involved in furnishing
the services is similar to the in-person critical care service codes,
not that all elements of the services are the same. Many services paid
under the PFS share similar, if not exactly the same work RVUs, without
necessarily describing the exact same elements of the service. For more
on the critical care consultation codes in the context of telehealth,
please see the CY 2017 PFS final rule (81 FR 80196 through 80197 and 81
FR 80352).
Comment: Several commenters disagreed with our decision not to add
various physical and occupational therapy, and speech language
pathology services to the Medicare telehealth list.
Response: As noted above, the majority of the codes requested are
furnished by therapy professionals over 90 percent of the time, and we
believe that adding therapy services to the telehealth list that are
furnished by professionals not included on the statutory list of
distant site practitioners could result in confusion about who is
authorized to bill for these services when furnished via telehealth.
Additionally, some of the codes involve physical manipulation of the
patient, which cannot be accomplished via an interactive
telecommunications system.
Comment: Several commenters responded to our decision not to remove
the requirement for a monthly in-person visit to examine the catheter
access site for ESRD services conducted via telehealth. Another
commenter encouraged CMS to lessen the requirements by making the in-
person visit a quarterly, as opposed to monthly, requirement. Other
commenters stated that the examination of the catheter access site
could be conducted remotely via telecommunications technology.
Response: We appreciate the feedback on our proposal and we will
consider the comments on the frequency of the examination of the
catheter access site and whether the examination could be conducted
remotely for future rulemaking.
Comment: One commenter disagreed with the decision not to propose
to add CPT code 99444 (online E/M) to the Medicare telehealth list,
stating that this service would increase access to care, especially for
follow-up visits and medication management.
Response: As we noted above, CPT code 99444 is currently non-
covered, so there is no Medicare payment for this service. As such,
there would be no payment for this service even if we were to add it to
the telehealth list. Additionally, because this service does not
describe a service typically furnished in-person, it would not be
considered a telehealth service under the applicable provisions of law.
For both of these reasons, we continue to believe that it would not be
appropriate to add CPT code 99444 to the Medicare telehealth list.
Comment: Many commenters provided recommendations for additional
services that could be added to the Medicare telehealth list, such as
an add-on code for patients requiring care planning for cognitive
impairment, follow-up care for liver transplant patients, emergency
department visits, oncology and podiatric-specific services, eConsult
services, Medical Nutrition Therapy (MNT), and Diabetes Self Management
Training (DSMT).
[[Page 53012]]
Response: We thank commenters for these suggestions and will
consider these for future notice and comment rulemaking. We also wish
to remind commenters that requests for specific services to be added to
the Medicare telehealth list can be submitted until December 31st of
each calendar year to be considered for the next rulemaking cycle. For
more information on submitting a request for an addition to the list of
Medicare telehealth services, including where to mail these requests,
see our Web site at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
Since several commenters requested that we add MNT and DSMT to the
telehealth list, we also wish to remind commenters that codes for both
MNT and DSMT are currently on the Medicare telehealth list. The current
list of Medicare telehealth services can be viewed on our Web site,
https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes.html.
4. Elimination of the Required Use of the GT Modifier on Professional
Claims
We have required distant site practitioners to report one of two
longstanding HCPCS modifiers when reporting telehealth services.
Current guidance instructs practitioners to submit claims for
telehealth services using the appropriate CPT or HCPCS code for the
professional service along with the telehealth modifier GT (via
interactive audio and video telecommunications systems). For federal
telemedicine demonstration programs in Alaska or Hawaii, practitioners
are instructed to submit claims using the appropriate CPT or HCPCS code
for the professional service along with the telehealth modifier GQ if
telehealth services are performed ``via an asynchronous
telecommunications system.'' By coding and billing these modifiers with
a service code, practitioners are certifying that both the broad and
code-specific telehealth requirements have been met.
In the CY 2017 PFS final rule (81 FR 80201), we finalized payment
policies regarding Medicare's use of a new Place of Service (POS) Code
describing services furnished via telehealth. The new POS code became
effective January 1, 2017, and we believe its use is redundant with the
requirements to apply the GT modifier for telehealth services. We did
not propose to implement a change to the modifier requirements during
CY 2017 rulemaking because at the time of the CY 2017 PFS proposed
rule, we did not know whether the telehealth POS code would be made
effective for January 1, 2017. However, we noted in the CY 2017 PFS
final rule that, like the modifiers, use of the telehealth POS code
certifies that the service meets the telehealth requirements.
Because a valid POS code is required on professional claims for all
services, and the appropriate reporting of the telehealth POS code
serves to indicate both the provision of the service via telehealth and
certification that the requirements have been met, we believe that it
is unnecessary to also require the distant site practitioner report the
GT modifier on the claim. Therefore, we proposed to eliminate the
required use of the GT modifier on professional claims. Because
institutional claims do not use a POS code, we proposed for distant
site practitioners billing under CAH Method II to continue to use the
GT modifier on institutional claims. For purposes of the federal
telemedicine demonstration programs in Alaska or Hawaii, we proposed to
retain the GQ modifier to maintain the distinction between synchronous
and asynchronous telehealth services, as reflected in statute.
The following is a summary of the public comments received on our
proposal to eliminate the required use of the GT modifier on
professional claims:
Comment: The majority of the commenters were supportive of
eliminating the required use of the GT modifier on professional claims
and agreed that this would reduce administrative burden.
Response: We thank the commenters for their support of the
proposal. After considering the public comments, we are finalizing the
proposal to eliminate the required use of the GT modifier on
professional claims.
Comment: One commenter supported the proposal to no longer require
the GT modifier on professional claims, but requested that we not
delete the GT modifier because other payers who receive Medicare
crossover claims might still require its use.
Response: We appreciate the commenters' concerns and reiterate that
the GT modifier will be retained for Medicare for use in CAH Method II
billing. Our decision to no longer use the modifier for professional
claims will not affect its use in other appropriate circumstances.
Comment: One commenter stated that there is significant effort
involved in updating computer systems to use the new POS code rather
than a modifier, and encouraged CMS to consider that in future
rulemaking.
Response: We appreciate the comment. We note that the required use
of the telehealth POS code was finalized for CY 2017; however, we have
a continuing interest in reducing administrative burden and will
consider this for future rulemaking.
Comment: One commenter urged CMS to adopt a uniform method for
identification of telehealth services and suggested that we use the 95
modifier, the new CPT modifier for CY 2017.
Response: We appreciate the comment, especially with the
possibility that this could reduce administrative burdens associated
with multiple modifiers. We will consider use of the 95 modifier for
this purpose for future rulemaking.
Comment: A few commenters noted that the policy on the telehealth
place of service (POS) code that was finalized for CY 2017 and took
effect on January 1, 2017 resulted in a decrease in payment for some
distant site practitioners furnishing services via telehealth in the
non-facility setting and one commenter requested that we reverse the
policy to pay the facility rate for all services furnished via
telehealth.
Response: We understand the concerns raised about the current
policy of using the facility rate for payment to distant site
telehealth practitioners for telehealth services and will also further
consider this policy for future rulemaking.
5. Comment Solicitation on Medicare Telehealth Services
We have received numerous requests from stakeholders to expand
access to telehealth services. As noted above, Medicare payment for
telehealth services is restricted by statute, which establishes the
services initially eligible for Medicare telehealth and limits the use
of telehealth by defining both eligible originating sites (the location
of the beneficiary) and the distant site practitioners who may furnish
and bill for telehealth services. Originating sites are limited both by
geography and provider setting. We have the authority to add to the
list of telehealth services based on our annual process, but cannot
change the limitations relating to geography, patient setting, or type
of furnishing practitioner because these requirements are specified in
statute. For CY 2018, we sought information regarding ways that we
might further expand access to telehealth services within the current
statutory authority and pay appropriately for services that take full
advantage of communication technologies.
Comment: We received many thoughtful comments in response to the
[[Page 53013]]
comment solicitation. Commenters were very supportive of CMS expanding
access to telehealth services. Many commenters noted that Medicare
payment for telehealth services is restricted by statute, but
encouraged CMS to continue to explore alternate means to recognize and
support technological developments in healthcare. Commenters provided
many suggestions for how CMS could expand access to telehealth services
within the current statutory authority and pay appropriately for
services that take full advantage of communication technologies, such
as waiving portions of the statutory restrictions using demonstration
authority.
Response: We thank the commenters for their input. We reiterate our
commitment to expanding access to telehealth services consistent with
statutory authority, and paying appropriately for services that
maximize telecommunications technology. We will carefully review the
comments and consider commenters' suggestions for future rulemaking and
any appropriate sub-regulatory changes.
6. Comment Solicitation on Remote Patient Monitoring
In addition to the broad comment solicitation regarding Medicare
telehealth services, we also specifically solicited comment on whether
to make separate payment for CPT codes that describe remote patient
monitoring. We note that remote patient monitoring services would
generally not be considered Medicare telehealth services as defined
under section 1834(m) of the Act. Rather, like the interpretation by a
physician of an actual electrocardiogram or electroencephalogram
tracing that has been transmitted electronically, these services
involve the interpretation of medical information without a direct
interaction between the practitioner and beneficiary. As such, they are
paid under the same conditions as in-person physicians' services with
no additional requirements regarding permissible originating sites or
use of the telehealth place of service code.
We noted we were particularly interested in comments regarding CPT
code 99091 (Collection and interpretation of physiologic data (e.g.,
ECG, blood pressure, glucose monitoring) digitally stored and/or
transmitted by the patient and/or caregiver to the physician or other
qualified health care professional, qualified by education, training,
licensure/regulation (when applicable) requiring a minimum of 30
minutes of time). This code is currently assigned a procedure status of
B (bundled). As with many other bundled codes, we currently assign RVUs
for this code based on existing RUC recommendations, even though we
have considered the services described by the code to be bundled with
other services. In addition to comments on the payment status and
valuation for this code (the RUC-recommended value, specifically) we
sought information about the circumstances under which this code might
be reported for separate payment, including how to differentiate the
time related to these services from other services, including care
management services. For example, PFS payment for analysis of patient-
generated health data is considered included in chronic care management
(CCM) services (CPT codes 99487, 99489, and 99490) to the extent that
this activity is medically necessary and performed as part of CCM (see
the CY 2015 PFS final rule (79 FR 67727), CY 2016 PFS final rule (81 FR
80244), and the CMS FAQ available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/Payment_for_CCM_Services_FAQ.pdf). We also sought comment from
beneficiaries and beneficiary advocacy organizations on the value of
such services and what protections might be necessary to assure that
beneficiaries are properly informed that they are receiving a remote
monitoring service, since beneficiaries would be required to pay
standard cost sharing for such services. Finally, regarding CPT code
99091, we sought available information regarding potential utilization
assumptions we might make for the service for purposes of PFS
ratesetting, were we to make it payable for CY 2018 or in the future;
since making such assumptions would be necessary to implement separate
payment. We noted that since the PFS is a budget neutral system, any
increase in payment made for particular services would result in
decreases in payment for other services, and the degree of that
decrease would depend, in large part, on the utilization assumptions.
We also sought comment on other existing codes that describe
extensive use of communications technology for consideration for future
rulemaking, including CPT code 99090 (Analysis of clinical data stored
in computers (e.g., ECGs, blood pressures, hematologic data)). CPT code
99090 is also assigned a procedure status of B (bundled). CPT code
99090 also has a payment status of bundled; and we do not have RUC-
recommended values for this service, and therefore, currently do not
assign RVUs.
The following is a summary of the public comments received on our
proposals and our responses:
Comment: Commenters were generally supportive of CMS recognizing
the increasing importance of remote patient monitoring. Several
commenters recommended that CMS make separate payment for CPT code
99091. Other commenters acknowledged that the current code, which has
not been separately payable for some time, may not optimally describe
the services furnished using current technology. Some of these
commenters encouraged CMS to make the services separately payable for
CY 2018, but also noted that the CPT Editorial Panel is currently
working on codes that more accurately describe remote monitoring.
A few commenters expressed opposition to making CPT codes 99090
and/or 99091 separately payable, noting that these are generic codes
and are duplicative of other codes that are more specific, such as CPT
codes 93297 ((Interrogation device evaluation(s), (remote) up to 30
days; implantable cardiovascular monitor system, including analysis of
1 or more recorded physiologic cardiovascular data elements from all
internal and external sensors, analysis, review(s) and report(s) by a
physician or other qualified health care professional)) and CPT code
93228 (External mobile cardiovascular telemetry with
electrocardiographic recording, concurrent computerized real time data
analysis and greater than 24 hours of accessible ECG data storage
(retrievable with query) with ECG triggered and patient selected events
transmitted to a remote attended surveillance center for up to 30 days;
review and interpretation with report by a physician or other qualified
health care professional)). Several commenters encouraged CMS to wait
for the CPT Editorial Panel to complete its work of reviewing and
revising the CPT codes and consider valuing the new codes in the
future. Of the commenters who were supportive of unbundling and making
separate payment for CPT code 99091, a few suggested that CPT code
99091 could be billed in association with chronic care management (CCM)
services.
Response: We agree with commenters that monitoring services can be
a significant part of ongoing medical care and that we should recognize
these services for separate payment as soon as practicable. However, we
also agree with commenters that the two codes in question may not
optimally describe these services as currently furnished. In order to
reconcile these concerns,
[[Page 53014]]
especially considering the expectation that CPT coding revisions are
expected in the immediate future, we believe that activating CPT code
99091 for separate payment under Medicare for 2018 will serve to
facilitate appropriate payment for these services in the short term.
Unlike CPT code 99090, CPT code 99091 specifies that the information is
interpreted by a physician or other qualified health care professional,
and it specifies that this activity requires a minimum of 30 minutes of
time. After consideration of these differences between the two CPT
codes, and after consideration of the public comments recommending that
we make separate payment for CPT code 99091, we were persuaded to
change the status of CPT code 99091 from bundled to active for CY 2018.
In addition, as noted in the CY 2018 PFS proposed rule, the RUC had
already provided CMS with RVUs for CPT code 99091, whereas it did not
provide CMS with RVUs for CPT code 99090. Also, we did not receive
specific comments to suggest reasons for changing CPT code 99090 to
``active'' status, so we are retaining the ``bundled'' status for that
code. We will consider whether to adopt and establish relative value
units for CPT codes that may be developed by the CPT Editorial Panel
under our standard process for future years through notice and comment
rulemaking. However, the comments make it clear to us that separate
payment for this code will not mitigate the need for coding revisions.
In order to account for some of the concerns raised by commenters
regarding the broad nature of the code that describes professional
collection and interpretation of the stored patient data, we believe
that we can apply some of the current requirements regarding chronic
care management services (CCM) to identify circumstances appropriate
for reporting the code. Specifically, given the non face-to-face nature
of the services described by CPT code 99091, we are requiring that the
practitioner obtain advance beneficiary consent for the service and
document this in the patient's medical record. Additionally, for new
patients or patients not seen by the billing practitioner within 1 year
prior to billing CPT code 99091, we are requiring initiation of the
service during a face-to-face visit with the billing practitioner, such
as an Annual Wellness Visit or Initial Preventive Physical Exam, or
other face-to-face visit with the billing practitioner. Levels 2
through 5 E/M visits (CPT codes 99212 through 99215) would qualify as
the face-to-face visit. However, services that do not involve a face-
to-face visit by the billing practitioner or are not separately payable
under the PFS (such as CPT code 99211, anticoagulant management, online
services, telephone and other E/M services) do not qualify as
initiating visits. The face-to-face visit included in transitional care
management (TCM) services (CPT codes 99495 and 99496) would also
qualify. We are also adopting the prefatory language for CPT code
99091, including the requirement that it ``should be reported no more
than once in a 30-day period to include the physician or other
qualified health care professional time involved with data accession,
review and interpretation, modification of care plan as necessary
(including communication to patient and/or caregiver), and associated
documentation.''
Finally, because we believe the kind of analysis involved in
furnishing this service is complementary to CCM and other care
management services, for the purposes of Medicare billing, we are
allowing that CPT code 99091 can be billed once per patient during the
same service period as CCM (CPT codes 99487, 99489, and 99490), TCM
(CPT codes 99495 and 99496), and behavioral health integration (BHI)
(CPT codes 99492, 99493, 99494, and 99484). We note that under current
billing rules, time counted toward the CCM codes generally refers to
time spent by clinical staff furnishing care management services; while
CPT code 99091 refers to practitioner time. We note that time spent
furnishing these services could not be counted towards the required
time for both codes for a single month.
We also note that the new separate payment for CPT code 99091 will
be excluded from the calculation of the net reduction in expenditures
due to changes in coding and valuation for purposes of the misvalued
code target, consistent with policies finalized in the CY 2016 PFS
final rule with comment period (80 FR 70926). CPT code 99091 describes
a service that is newly separately reportable, but for which no
corresponding reduction is being made to existing codes and instead
reductions under the PFS are being taken exclusively through a budget
neutrality adjustment.
We look forward to forthcoming coding changes through the CPT
process that we anticipate will better describe the role of remote
patient monitoring in contemporary practice and potentially mitigate
the need for the additional billing requirements associated with these
services.
7. Telehealth Originating Site Facility Fee Payment Amount Update
Section 1834(m)(2)(B) of the Act established the Medicare
telehealth originating site facility fee for telehealth services
furnished from October 1, 2001 through December 31, 2002, at $20.00.
For telehealth services furnished on or after January 1 of each
subsequent calendar year, the telehealth originating site facility fee
is increased by the percentage increase in the Medicare Economic Index
(MEI) as defined in section 1842(i)(3) of the Act. The originating site
facility fee for telehealth services furnished in CY 2017 is $25.40.
The MEI increase for 2018 is 1.4 percent and is based on the most
recent historical update through 2017Q2 (1.8 percent), and the most
recent historical MFP through calendar year 2016 (0.4 percent).
Therefore, for CY 2018, the payment amount for HCPCS code Q3014
(Telehealth originating site facility fee) is 80 percent of the lesser
of the actual charge or $25.76. The Medicare telehealth originating
site facility fee and the MEI increase by the applicable time period is
shown in Table 8.
Table 8--The Medicare Telehealth Originating Site Facility Fee
------------------------------------------------------------------------
Time period MEI increase Facility fee
------------------------------------------------------------------------
10/01/2001-12/31/2002................... N/A $20.00
01/01/2003-12/31/2003................... 3 20.60
01/01/2004-12/31/2004................... 2.9 21.20
01/01/2005-12/31/2005................... 3.1 21.86
01/01/2006-12/31/2006................... 2.8 22.47
01/01/2007-12/31/2007................... 2.1 22.94
01/01/2008-12/31/2008................... 1.8 23.35
01/01/2009-12/31/2009................... 1.6 23.72
01/01/2010-12/31/2010................... 1.2 24.00
01/01/2011-12/31/2011................... 0.4 24.10
[[Page 53015]]
01/01/2012-12/31/2012................... 0.6 24.24
01/01/2013-12/31/2013................... 0.8 24.43
01/01/2014-12/31/2014................... 0.8 24.63
01/01/2015-12/31/2015................... 0.8 24.83
01/01/2016-12/31/2016................... 1.1 25.10
01/01/2017-12/31/2017................... 1.2 25.40
01/01/2018-12/31/2018................... 1.4 25.76
------------------------------------------------------------------------
E. Potentially Misvalued Services Under the Physician Fee Schedule
1. Background
Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a
periodic review, not less often than every 5 years, of the RVUs
established under the PFS. Section 1848(c)(2)(K) of the Act requires
the Secretary to periodically identify potentially misvalued services
using certain criteria and to review and make appropriate adjustments
to the relative values for those services. Section 1848(c)(2)(L) to the
Act also requires the Secretary to develop a process to validate the
RVUs of certain potentially misvalued codes under the PFS, using the
same criteria used to identify potentially misvalued codes, and to make
appropriate adjustments.
As discussed in section II.H. of this final rule, each year we
develop appropriate adjustments to the RVUs taking into account
recommendations provided by the American Medical Association/Specialty
Society Relative Value Scale Update Committee (RUC), the Medicare
Payment Advisory Commission (MedPAC), and others. For many years, the
RUC has provided us with recommendations on the appropriate relative
values for new, revised, and potentially misvalued PFS services. We
review these recommendations on a code-by-code basis and consider these
recommendations in conjunction with analyses of other data, such as
claims data, to inform the decision-making process as authorized by
law. We may also consider analyses of work time, work RVUs, or direct
PE inputs using other data sources, such as Department of Veteran
Affairs (VA), National Surgical Quality Improvement Program (NSQIP),
the Society for Thoracic Surgeons (STS), and the Physician Quality
Reporting System (PQRS) databases. In addition to considering the most
recently available data, we assess the results of physician surveys and
specialty recommendations submitted to us by the RUC for our review. We
also consider information provided by other stakeholders. We conduct a
review to assess the appropriate RVUs in the context of contemporary
medical practice. We note that section 1848(c)(2)(A)(ii) of the Act
authorizes the use of extrapolation and other techniques to determine
the RVUs for physicians' services for which specific data are not
available and requires us to take into account the results of
consultations with organizations representing physicians who provide
the services. In accordance with section 1848(c) of the Act, we
determine and make appropriate adjustments to the RVUs.
In its March 2006 Report to the Congress (http://www.medpac.gov/docs/default-source/congressional-testimony/testimony-report-to-the-congress-medicare-payment-policy-march-2006-.pdf?sfvrsn=0), MedPAC
discussed the importance of appropriately valuing physicians' services,
noting that misvalued services can distort the market for physicians'
services, as well as for other health care services that physicians
order, such as hospital services. In that same report, MedPAC
postulated that physicians' services under the PFS can become misvalued
over time. MedPAC stated, ``When a new service is added to the
physician fee schedule, it may be assigned a relatively high value
because of the time, technical skill, and psychological stress that are
often required to furnish that service. Over time, the work required
for certain services would be expected to decline as physicians become
more familiar with the service and more efficient in furnishing it.''
We believe services can also become overvalued when PE declines. This
can happen when the costs of equipment and supplies fall, or when
equipment is used more frequently than is estimated in the PE
methodology, reducing its cost per use. Likewise, services can become
undervalued when physician work increases or PE rises.
As MedPAC noted in its March 2009 Report to Congress (http://www.medpac.gov/docs/default-source/reports/march-2009-report-to-congress-medicare-payment-policy.pdf), in the intervening years since
MedPAC made the initial recommendations, CMS and the RUC have taken
several steps to improve the review process. Also, section
1848(c)(2)(K)(ii) of the Act augments our efforts by directing the
Secretary to specifically examine, as determined appropriate,
potentially misvalued services in the following categories:
Codes that have experienced the fastest growth.
Codes that have experienced substantial changes in
practice expenses.
Codes that describe new technologies or services within an
appropriate time period (such as 3 years) after the relative values are
initially established for such codes.
Codes which are multiple codes that are frequently billed
in conjunction with furnishing a single service.
Codes with low relative values, particularly those that
are often billed multiple times for a single treatment.
Codes that have not been subject to review since
implementation of the fee schedule.
Codes that account for the majority of spending under the
physician fee schedule.
Codes for services that have experienced a substantial
change in the hospital length of stay or procedure time.
Codes for which there may be a change in the typical site
of service since the code was last valued.
Codes for which there is a significant difference in
payment for the same service between different sites of service.
Codes for which there may be anomalies in relative values
within a family of codes.
Codes for services where there may be efficiencies when a
service is furnished at the same time as other services.
Codes with high intra-service work per unit of time.
Codes with high practice expense relative value units.
Codes with high cost supplies.
Codes as determined appropriate by the Secretary.
[[Page 53016]]
Section 1848(c)(2)(K)(iii) of the Act also specifies that the
Secretary may use existing processes to receive recommendations on the
review and appropriate adjustment of potentially misvalued services. In
addition, the Secretary may conduct surveys, other data collection
activities, studies, or other analyses, as the Secretary determines to
be appropriate, to facilitate the review and appropriate adjustment of
potentially misvalued services. This section also authorizes the use of
analytic contractors to identify and analyze potentially misvalued
codes, conduct surveys or collect data, and make recommendations on the
review and appropriate adjustment of potentially misvalued services.
Additionally, this section provides that the Secretary may coordinate
the review and adjustment of any RVU with the periodic review described
in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of
the Act specifies that the Secretary may make appropriate coding
revisions (including using existing processes for consideration of
coding changes) that may include consolidation of individual services
into bundled codes for payment under the physician fee schedule.
2. Progress in Identifying and Reviewing Potentially Misvalued Codes
To fulfill our statutory mandate, we have identified and reviewed
numerous potentially misvalued codes as specified in section
1848(c)(2)(K)(ii) of the Act, and we plan to continue our work
examining potentially misvalued codes in these areas over the upcoming
years. As part of our current process, we identify potentially
misvalued codes for review, and request recommendations from the RUC
and other public commenters on revised work RVUs and direct PE inputs
for those codes. The RUC, through its own processes, also identifies
potentially misvalued codes for review. Through our public nomination
process for potentially misvalued codes established in the CY 2012 PFS
final rule with comment period, other individuals and stakeholder
groups submit nominations for review of potentially misvalued codes as
well.
Since CY 2009, as a part of the annual potentially misvalued code
review and Five-Year Review process, we have reviewed approximately
1,700 potentially misvalued codes to refine work RVUs and direct PE
inputs. We have assigned appropriate work RVUs and direct PE inputs for
these services as a result of these reviews. A more detailed discussion
of the extensive prior reviews of potentially misvalued codes is
included in the CY 2012 PFS final rule with comment period (76 FR 73052
through 73055). In the CY 2012 PFS final rule with comment period (76
FR 73055 through 73958), we finalized our policy to consolidate the
review of physician work and PE at the same time, and established a
process for the annual public nomination of potentially misvalued
services.
In the CY 2013 PFS final rule with comment period, we built upon
the work we began in CY 2009 to review potentially misvalued codes that
have not been reviewed since the implementation of the PFS (so-called
``Harvard-valued codes''). In CY 2009 (73 FR 38589), we requested
recommendations from the RUC to aid in our review of Harvard-valued
codes that had not yet been reviewed, focusing first on high-volume,
low intensity codes. In the fourth Five-Year Review (76 FR 32410), we
requested recommendations from the RUC to aid in our review of Harvard-
valued codes with annual utilization of greater than 30,000 services.
In the CY 2013 PFS final rule with comment period, we identified
specific Harvard-valued services with annual allowed charges that total
at least $10,000,000 as potentially misvalued. In addition to the
Harvard-valued codes, in the CY 2013 PFS final rule with comment period
we finalized for review a list of potentially misvalued codes that have
stand-alone PE (codes with physician work and no listed work time and
codes with no physician work that have listed work time).
In the CY 2016 PFS final rule with comment period, we finalized for
review a list of potentially misvalued services, which included eight
codes in the neurostimulators analysis-programming family (CPT 95970-
95982). We also finalized as potentially misvalued 103 codes identified
through our screen of high expenditure services across specialties.
In the CY 2017 PFS final rule, we finalized for review a list of
potentially misvalued services, which included eight codes in the end-
stage renal disease home dialysis family (CPT codes 90963-90970). We
also finalized as potentially misvalued 19 codes identified through our
screen for 0-day global services that are typically billed with an
evaluation and management (E/M) service with modifier 25.
3. CY 2018 Identification and Review of Potentially Misvalued Services
In the CY 2012 PFS final rule with comment period (76 FR 73058), we
finalized a process for the public to nominate potentially misvalued
codes. The public and stakeholders may nominate potentially misvalued
codes for review by submitting the code with supporting documentation
by February 10 of each year. Supporting documentation for codes
nominated for the annual review of potentially misvalued codes may
include the following:
Documentation in peer reviewed medical literature or other
reliable data that there have been changes in physician work due to one
or more of the following: Technique, knowledge and technology, patient
population, site-of-service, length of hospital stay, and work time.
An anomalous relationship between the code being proposed
for review and other codes.
Evidence that technology has changed physician work.
Analysis of other data on time and effort measures, such
as operating room logs or national and other representative databases.
Evidence that incorrect assumptions were made in the
previous valuation of the service, such as a misleading vignette,
survey, or flawed crosswalk assumptions in a previous evaluation.
Prices for certain high cost supplies or other direct PE
inputs that are used to determine PE RVUs are inaccurate and do not
reflect current information.
Analyses of work time, work RVU, or direct PE inputs using
other data sources (for example: Department of Veteran Affairs (VA)
National Surgical Quality Improvement Program (NSQIP), the Society for
Thoracic Surgeons (STS) National Database, and the Physician Quality
Reporting System (PQRS) databases).
National surveys of work time and intensity from
professional and management societies and organizations, such as
hospital associations.
We evaluate the supporting documentation submitted with the
nominated codes and assess whether the nominated codes appear to be
potentially misvalued codes appropriate for review under the annual
process. In the following year's PFS proposed rule, we publish the list
of nominated codes and indicate whether we proposed each nominated code
as a potentially misvalued code. The public has the opportunity to
comment on these and all other proposed potentially misvalued codes. In
that year's final rule, we finalize our list of potentially misvalued
codes.
[[Page 53017]]
a. Public Nomination of Arthrodesis of Sacroiliac Joint (CPT Code
27279)
After we issued the CY 2017 PFS final rule, we received a
nomination and supporting documentation for one code to be considered
as potentially misvalued. We evaluated the supporting documentation for
this nominated code to ascertain whether the submitted information
demonstrated that the code should be proposed as potentially misvalued.
CPT code 27279 (Arthrodesis, sacroiliac joint, percutaneous or
minimally invasive (indirect visualization), with image guidance,
includes obtaining bone graft when performed, and placement of
transfixing device) was nominated for review as a potentially misvalued
code because the current work RVU is potentially undervalued and
stakeholders recommended that it should be increased to 14.23. We
proposed this code as a potentially misvalued code in the CY 2018 PFS
proposed rule.
The following is a summary of the public comments received on
whether CPT code 27279 should be reviewed under the misvalued code
initiative and our responses:
Comment: One commenter disagreed with CMS' proposal of CPT code
27279 as potentially misvalued, while many other commenters supported
the proposal because they believe the service is significantly
undervalued relative to other PFS services. While some commenters
suggested the work RVU should be increased relative to other joint
replacement procedures, like CPT code 63030 (Laminotomy
(hemilaminectomy), with decompression of nerve root(s), including
partial facetectomy, foraminotomy and/or excision of herniated
intervertebral disc; 1 interspace, lumbar) which has a work RVU of
13.18, other commenters recommended increasing the work RVU to 14.23
because they stated that value better reflects the technical difficulty
and increased time required to perform the procedure. Other commenters
suggested specific work RVUs that were higher than 14.23 for similar
reasons.
A few commenters noted that CPT code 27279 is scheduled for review
by the RUC in October 2018 as part of its standard review process. As a
result, some commenters suggested that CMS should wait until the RUC
makes a recommendation regarding the appropriate valuation of the code.
Some commenters noted that the RUC intends to review this service in
October 2018 and suggested that the timeframe for that review would
mean that the code could not be appropriately valued prior to CY 2020.
Response: After reviewing the range of public comments, we agree
with commenters that CPT code 27279 is a potentially misvalued, and
believe that a comprehensive review of the code values is warranted.
While we appreciate the comments that included suggestions
regarding the specific work RVUs that might represent more appropriate
valuation, we agree with those commenters that urged us to wait for the
code to be reviewed by the RUC. We note that should the RUC and other
relevant stakeholders expedite their review process, we would be able
to consider making changes during next year's rulemaking. If the RUC
review process is not completed in time, we may not be able to make
changes in next year's rulemaking and would wait for the RUC to
complete its process before making changes in subsequent rulemaking.
b. Comment Solicitation on Dialysis Vascular Access Codes (CPT Codes
36901-36909)
In the CY 2017 PFS final rule, we noted that the assertions by some
commenters regarding appropriate values for the dialysis vascular
access codes newly created in CY 2017 (CPT codes 36901 through 36909)
did not include data that would warrant increases to the work RVUs we
proposed and finalized in that rule (81 FR 80290-80297). However, we
urged interested stakeholders to consider submitting robust data
regarding costs for these and other services (81 FR 80290-80297). We
have continued to receive feedback from stakeholders regarding the work
valuation of these codes. Stakeholders have expressed concerns
regarding the typical patient for these procedures as reflected in the
information included in the RUC recommendations for CY 2017 and the
importance of appropriate payment for ensuring access to care for
Medicare beneficiaries. Therefore, we sought additional comment and
requested robust data regarding the potentially misvalued work RVUs for
CPT codes 36901 through 36909 and considered alternate work valuations
for CY 2018, such as the RUC-recommended work RVUs from CY 2017, or
other potential values based on submission of data through the public
comment process. We noted that the RUC-recommended work RVUs for these
services were displayed in the CY 2017 PFS final rule (81 FR 80290
through 80296).
The following is a summary of the public comments received on CPT
codes 36901-36909 and our responses:
Comment: Many commenters were concerned that the values currently
assigned to the dialysis circuit family of codes have already and will
continue to compromise patient access to vascular access services; with
one commenter specifically requesting that CMS promptly reevaluate
these codes. Several commenters supported increases to the work RVUs
and explained that the greater complexity of the patient population for
these services involved greater relative intensity than other services,
especially since the codes involve obtaining new access as well as
secondary access to the dialysis circuit, while the codes used as
crosswalks for the current valuation involve colonoscopy through an
existing access.
The overwhelming majority of commenters suggested we finalize the
CY 2017 RUC-recommended work RVUs for CPT codes 36901-36909.
Response: We appreciate commenters' responses to our request for
new information. After further reflection, we are persuaded by
commenters' explanations regarding the complexities of care related to
this patient population specifically and after reviewing these
additional remarks, agree that these services are currently misvalued.
Therefore for CY 2018, we are finalizing the CY 2017 RUC-recommended
work RVUs for CPT codes 36901-36909, consistent with the requests of
public commenters.
c. CMS Nomination of Flow Cytometry Codes (CPT Codes 88184 and 88185)
We have received conflicting information about the direct PE inputs
for CPT codes 88184 (Flow cytometry, cell surface, cytoplasmic, or
nuclear marker, technical component only; first marker) and 88185 (Flow
cytometry, cell surface, cytoplasmic, or nuclear marker, technical
component only; each additional marker (List separately in addition to
code for first marker)). In the CY 2018 PFS proposed rule, we proposed
these codes as potentially misvalued so that they can be reviewed again
because some stakeholders have suggested the clinical labor and
supplies that were previously finalized are no longer accurate.
Comment: We received several comments regarding various clinical
labor and supply inputs for CPT codes 88184 and 88185 urging CMS to use
the RUC recommendations for CY 2017 in developing final PE RVUs for
these services instead of recommending additional review of these codes
under the misvalued code initiative.
Response: We appreciate these comments and, based on this
[[Page 53018]]
suggestion, we have re-examined the CY 2017 RUC-recommended direct PE
inputs for these services in light of specific comments. We refer
readers to section II.H of this final rule. This section describes the
direct PE input changes between CY 2017 and CY 2018 for specific
services.
d. Comment Solicitation on Emergency Department Payment Rates (CPT
Codes 99281-99385)
We received information suggesting that the work RVUs for emergency
department visits did not appropriately reflect the full resources
involved in furnishing these services. Specifically, stakeholders
expressed concerns that the work RVUs for these services have been
undervalued given the increased acuity of the patient population and
the heterogeneity of the sites, such as freestanding and off-campus
emergency departments, where emergency department visits are furnished.
Therefore, we sought comment on whether CPT codes 99281-99385
(Emergency department visits for the evaluation and management of a
patient) should be reviewed under the misvalued code initiative.
The following is a summary of the public comments received on
whether CPT codes 99281-99385 should be reviewed under the misvalued
code initiative and our responses:
Comment: Most commenters had no objection to review of these codes.
Several commenters stated that the work RVUs for the emergency
department evaluation and management (E/M) services, like most other E/
M services, are undervalued given the increased acuity of the patient
population and the heterogeneity of the sites where emergency
department visits are furnished. One commenter suggested that CMS
evaluate alternatives to the misvalued code initiative for review of
these codes, but another commenter explicitly stated that review of
these services should be undertaken by the RUC rather than CMS. In its
comment, the RUC stated if CMS finalizes the codes as potentially
misvalued, it will add these codes to its list of potentially misvalued
services.
In contrast, one commenter stated that the problem of under-
reimbursement for these services would be better addressed by
streamlining the E/M process for documenting the higher level of care.
Another commenter stated that given the significant changes to
documentation guidelines for E/M services that may be forthcoming in
this rule cycle, it is premature and somewhat difficult to advise on
potential revaluation of any E/M codes, pending details on how the
documentation guideline revisions are resolved.
Response: We agree with the majority of commenters that these
services may be potentially misvalued given the increased acuity of the
patient population and the heterogeneity of the sites where emergency
department visits are furnished. As a result, we look forward to
reviewing the RUC's recommendations regarding the appropriate valuation
of these services for our consideration in future notice and comment
rulemaking. Additionally, regarding the commenters' concerns about
documentation guidelines for E/M services, we refer readers to section
II.I for details regarding our comment solicitation on documentation
for E/M guidelines more generally.
e. Comment Solicitation on New Potentially Misvalued Code Screens
For over a decade, CMS has collaborated with the RUC to regularly
prioritize codes for review by using the categories specified in the
statute or as determined appropriate. We generally have referred to
these categories as ``misvalued code screens.'' To supplement ongoing
RUC identification of potentially misvalued codes through established
screens, CMS regularly uses PFS rulemaking to identify other screens
for use in identifying potentially misvalued codes. For example, in
recent years, CMS has prioritized the following screens:
Codes with low work RVUs commonly billed in multiple units
per single encounter.
Codes with high volume and low work RVUs.
Codes with site-of-service-anomalies.
E/M codes.
PFS high expenditure services.
Services with standalone PE procedure time.
Services with anomalous time.
Contractor Medical Director identified potentially
misvalued codes.
Codes with higher total Medicare payments in office than
in hospital or ASC.
Publicly nominated potentially misvalued codes.
0-day global services that are typically billed with an
evaluation and management (E/M) service with modifier 25.
Although we did not propose a new screen for CY 2018, we continue
to believe that it is important to prioritize codes for review under
the misvalued code initiative. As a result, we solicited public comment
on the best approach for developing screens, as well as what particular
new screens we might consider. We will consider these comments for
future rulemaking.
The following is a summary of the public comments received on the
best approach for developing screens, as well as what particular new
screens we might consider and our responses:
Comment: One commenter suggested revisiting two recent efforts
funded by CMS, reports by the Urban Institute and RAND, for
prioritization of codes for review under the misvalued code initiative.
Both reports include examination on the relationship between service
times and work RVUs, in some cases for specific services. One commenter
suggested that we no longer utilize potentially misvalued code screens
due to the burden it causes the specialty societies. Other commenters
suggest that CMS work in collaboration with the RUC to identify
potentially misvalued codes and to not re-review codes that were
recently reviewed by the RUC.
Response: We thank commenters for their input and will consider all
recommendations for future rulemaking.
F. Payment Incentive for the Transition from Traditional X-Ray Imaging
to Digital Radiography and Other Imaging Services
Section 502(a)(1) of Division O, Title V of the Consolidated
Appropriations Act of 2016 (Pub. L. 114-113) amended section 1848(b) of
the Act by establishing a new paragraph (9) of subsection (b). Section
1848(b)(9)(B) of the Act provides for a 7 percent reduction in payments
for the technical component (TC) for imaging services made under the
PFS that are X-rays (including the technical component portion of a
global service) taken using computed radiography technology furnished
during CYs 2018 through 2022, and for a 10 percent reduction for the
technical component of such imaging services furnished during CY 2023
or a subsequent year. Computed radiography technology is defined for
purposes of this paragraph as cassette-based imaging that utilizes an
imaging plate to create the image involved. Section 1848(b)(9) of the
Act also requires implementation of the reduction in payments through
appropriate mechanisms, which can include the use of modifiers. In
accordance with section 1848(c)(2)(B)(v)(X) of the Act, the adjustments
under section 1848(b)(9)(A) of the Act are exempt from the budget
neutrality requirement.
We stated in the CY 2017 PFS proposed rule that because the
required reductions in PFS payment for the TC
[[Page 53019]]
of imaging services (including the TC portion of a global service) that
are X-rays taken using computed radiography technology did not apply
for CY 2017, we would address implementation of section 1848(b)(9)(B)
of the Act in future rulemaking. Therefore, to implement the provisions
of section 1848(b)(9)(B) of the Act relating to the payment reduction
for the TC (including the TC portion of a global service) of X-rays
taken using computed radiography technology during CY 2018 or
subsequent years, we proposed in the CY 2018 PFS proposed rule to
establish a new modifier to be used on claims for these services.
We proposed that beginning January 1, 2018, this modifier would be
required to be used when reporting imaging services for which payment
is made under the PFS that are X-rays (including the X-ray component of
a packaged service) taken using computed radiography technology. The
modifier would be required on claims for the technical component of the
X-ray service, including when the service is billed globally because
the PFS payment adjustment is made to the technical component
regardless of whether it is billed globally, or billed separately using
the TC modifier. The modifier must be used to report the specific
services that are subject to the payment reduction and accurate use is
subject to audit. The use of this proposed modifier to indicate an X-
ray taken using computed radiography would result in a 7 percent
reduction for CYs 2018 through 2022 and a 10 percent reduction for CY
2023 or a subsequent calendar year to the payments for the TC for such
imaging services furnished as specified under section 1848(b)(9)(B) of
the Act.
The following is a summary of the public comments received and our
responses:
Comment: One commenter noted support for the computed radiography
to digital X-ray payment differential but sought clarification
regarding its implementation. The commenter stated that a new modifier
will be designated to denote the CPT codes for computed radiography and
HCPCS X-ray codes that are subject to the payment reduction; however,
no listing of such codes was provided in the proposed rule. The
commenter noted that similarly last year it requested a listing of the
X-ray codes to which the modifier would apply. CMS declined to provide
such a list on the basis that the payment differential would apply to
any service performed using the film X-rays. The commenter stated that
the listing of the film and computed radiography CPT and HCPCS codes
would facilitate easy implementation, prevent ambiguity, be less
burdensome, and prevent risk of audit.
Response: We considered the commenter's concerns and recommendation
that we maintain a list of CPT and HCPCS codes to which the policy
applies. However, we do not agree that such a list would facilitate
easy implementation, prevent ambiguity, be less burdensome, or prevent
the risk of audit. We believe that the professionals who furnish and
bill for these services are in the best position to determine whether a
particular imaging service is appropriately described as X-rays taken
using computed radiography.
Comment: Some commenters expressed concern that rural and
underserved areas are particularly penalized by this provision and that
the use of a modifier places a burden on all providers and creates
another opportunity for miscoding.
Response: We appreciate the commenters' concerns, but under current
law, we do not currently believe that we have authority to provide
exemptions from the policy. We believe that the use of a modifier is
the least burdensome method to identify the services to which the
payment reduction applies, and to implement the required payment
reduction for services that are X-rays taken using computed
radiography.
Comment: One commenter opined that the continued overall trend in
imaging payment reductions is not sustainable for any quality imaging
provider and that CMS should look for more creative solutions such as
the AUC program, as well as reductions in mandated reporting.
Response: We thank the commenter for the suggestions and will take
these recommendations into consideration for future rulemaking.
Comment: One commenter requested that CMS work with Congress to
delay or eliminate the payment reductions, and ensure that clinicians
are thoroughly educated and outreach is provided to ensure that
stakeholders are thoroughly aware of the new requirements.
Response: We will include information to educate clinicians
regarding the new modifier requirement for services that are X-rays
taken using computed radiography as part of ongoing provider education
activities, though we acknowledge that we also appreciate assistance
from private, national organizations, such as medical specialty
societies in educating their membership. We appreciate the commenters'
concerns regarding the overall merits of the statutory provision, but
we do not believe that we have the authority to alter the application
of the provision.
Comment: Some commenters urged that physician practices be held
harmless from financial and criminal penalties if the new modifiers are
omitted or incorrectly applied at least for the first 3 years of the
program (2017-2019). In addition, the commenter stated that audits by
the Recovery Audit Contractors (RACs) related to the implementation of
the transition from traditional X-ray imaging to digital radiology
using the modifier should not be approved for the same time period.
Response: We appreciate these suggestions and concerns but note
that this final rule specifically addresses the payment policies
related to the statutory provision. The kinds of enforcement activities
addressed by these commenters are outside the scope of this final rule.
Comment: Some commenters supported the use of the modifier to
implement this requirement, but requested that the modifier be released
as soon as possible in order to allow radiology practices to work out
the logistics associated with compliance with the new requirement.
Response: To implement this provision, we created modifier ``FY''
(X-ray taken using computed radiography technology/cassette-based
imaging). Beginning in 2018, claims for X-rays taken using computed
radiography/cassette-based imaging must include modifier ``FY'' that
will result in the applicable payment reduction.
Comment: One commenter supported the use of the modifier as the
best indicator for the use of traditional X-rays or digital radiology.
Another commenter supported the transition to digital imaging services
because, according to the commenter, it is essential to reach
widespread interoperability.
Response: We thank commenters for their support.
After consideration of the public comments, we are finalizing the
proposal without modification.
G. Payment Rates Under the Medicare Physician Fee Schedule for
Nonexcepted Items and Services Furnished by Nonexcepted Off-Campus
Provider-Based Departments of a Hospital
1. Background
Sections 1833(t)(1)(B)(v) and (t)(21) of the Act require that
certain items and
[[Page 53020]]
services furnished by certain off-campus provider-based departments
(PBDs) (collectively referenced here as nonexcepted items and services
furnished by nonexcepted off-campus PBDs) shall not be considered
covered OPD services for purposes of payment under the OPPS, and
payment for those nonexcepted items and services furnished on or after
January 1, 2017 shall be made under the applicable payment system. In
the CY 2017 OPPS/ASC final rule with comment period (81 FR 79713), we
finalized the PFS as the ``applicable payment system'' for most
nonexcepted items and services furnished by off-campus PBDs.
As part of that discussion, we indicated that, in response to
public comments received on the proposed payment policies for
nonexcepted items and services, we would issue an interim final rule
with comment period (the CY 2017 interim final rule, 81 FR 79720
through 79729) to establish payment policies under the PFS for
nonexcepted items and services furnished on or after January 1, 2017.
In the following paragraphs, we summarize what we proposed for the
payment policies under the PFS for nonexcepted items and services
furnished during CY 2018. The CY 2017 interim final rule can be found
on the Internet at https://www.thefederalregister.org/fdsys/pkg/FR-2016-11-14/pdf/2016-26515.pdf.
2. Payment Mechanism
Coding and payment policies under the PFS have long recognized the
differences between the portions of services for which direct costs
generally are incurred by practitioners and the portions of services
for which direct costs generally are incurred by facilities. At
present, the coding and RVUs established for particular groups of
services under the PFS generally reflect such direct cost differences.
As described in section II.B of this final rule, we establish separate
nonfacility and facility RVUs for many HCPCS codes describing
particular services paid under the PFS. For many other services, we
establish separate RVUs for the professional component and the
technical component of the service described by the same HCPCS code.
For other services, we establish RVUs for the different HCPCS codes
that segregate and describe the discrete professional and technical
aspects of particular services.
Because hospitals with nonexcepted off-campus PBDs that furnish
nonexcepted items and services are likely to furnish a broader range of
services than other provider or supplier types for which there is a
separately valued technical component under the PFS, for CY 2017, we
established a new set of payment rates under the PFS that reflected the
relative resource costs of furnishing the technical component of a
broad range of services to be paid under the PFS specific to the
nonexcepted off-campus PBD of a hospital with packaging (bundling)
rules that are unique to the hospital outpatient setting under the
OPPS.
In principle, the coding and billing mechanisms required to make
appropriate payment to hospitals for nonexcepted items and services
furnished by nonexcepted off-campus PBDs are parallel to those used to
make payment for the technical component services for a range of
supplier types paid under the PFS. That is, payments to hospitals are
made for the technical aspect of services, while physicians and other
practitioners report the professional aspect of these same services. In
some cases, the entities reporting the technical aspect of services use
the same coding that is used by the individuals reporting the
professional services. In other cases, different coding applies. We
proposed to maintain this coding and billing mechanism for CY 2018.
Comment: A number of commenters supported our proposal to continue
to allow hospitals to bill using an institutional claim with the
modifier ``PN'' to indicate that the nonexcepted items and services are
furnished by nonexcepted PBDs.
Response: We appreciate the comments in support of our proposal to
allow hospitals to continue to bill for nonexcepted items and services
furnished by nonexcepted off-campus PBDs using an institutional claim
for CY 2018.
3. Establishment of Payment Rates
Using the relativity among OPPS payments to establish rates for the
nonexcepted items and services furnished by nonexcepted off-campus PBDs
and billed by hospitals under the PFS was only one aspect of
establishing the necessary relativity of these services under the PFS
more broadly. It was necessary to estimate the relativity of these
services compared to PFS services furnished in other settings paid
under the PFS. For CY 2017, we used our best estimate of the more
general relativity between the technical component of PFS services
furnished in nonexcepted off-campus PBDs and all other PFS services
furnished in other settings using the limited information available to
us at that time. As described in the CY 2017 interim final rule (81 FR
79722 through 79726), we estimated that for CY 2017, scaling the OPPS
payment rates downward by 50 percent would strike an appropriate
balance that avoided potentially underestimating the relative resources
involved in furnishing services in nonexcepted off-campus PBDs as
compared to the services furnished in other settings for which payment
was made under the PFS. Specifically, we established site-specific
rates under the PFS for the technical component of the broad range of
nonexcepted items and services furnished by nonexcepted off-campus PBDs
to be paid under the PFS that was based on the OPPS payment amount for
the same items and services, scaled downward by 50 percent. We called
this adjustment the ``PFS Relativity Adjuster.'' The PFS Relativity
Adjuster refers to the percentage of the OPPS payment amount paid under
the PFS for a nonexcepted item or service to the nonexcepted off-campus
PBD under this policy.
a. Methodology for Establishing CY 2017 PFS Relativity Adjuster
In developing the CY 2017 interim final rule, we began by analyzing
hospital outpatient claims data from January 1 through August 26, 2016,
that contained the ``PO'' modifier signifying that they were billed by
an off-campus department of a hospital paid under the OPPS other than a
remote location, a satellite facility, or a dedicated emergency
department (ED). We noted that the use of the ``PO'' modifier was a new
mandatory reporting requirement for CY 2016. We limited our analysis to
those claims billed on the 13X Type of Bill because those claims were
used for Medicare Part B billing under the OPPS. We then identified the
top (most frequently billed) 25 major codes that were billed by claim
line; that is, items and services that were separately payable or
conditionally packaged. Specifically, we restricted our analysis to
codes with OPPS status indicators ``J1'', ``J2'', ``Q1'', ``Q2'',
``Q3'', ``S'', ``T'', or ``V''. We did not include separately payable
drugs or biologicals in this analysis because those drugs or
biologicals were not paid under the PFS under the CY 2017 interim final
rule. As such, under the CY 2017 interim final rule, the PFS Relativity
Adjuster did not apply to separately payable drugs and biologicals
furnished by a nonexcepted off-campus PBD. Similarly, we excluded codes
assigned an OPPS status indicator ``A'' because the services described
by those codes were already paid at a rate under a fee schedule other
than the OPPS and payment for those nonexcepted items and services was
not changed by the rates established under
[[Page 53021]]
the CY 2017 interim final rule. Next, for the same major codes (or
analogous codes in the rare instance that different coding applies
under the OPPS than the PFS), we compared the CY 2016 payment rate
under the OPPS to a CY 2016 payment rate under the PFS attributable to
the nonprofessional relative resource costs involved in furnishing the
services.
The most frequently billed service with the ``PO'' modifier was
described by HCPCS code G0463 (Hospital outpatient clinic visit for
assessment and management of a patient), which is paid under APC 5012;
the total number of CY 2016 claim lines for that service was
approximately 6.7 million as of August 2016. In CY 2016, the OPPS
payment rate for APC 5012 was $102.12. Because there were multiple CPT
codes (CPT codes 99201 through 99215) used under the PFS for billing
that service, an exact comparison between the $102.12 OPPS payment rate
for APC 5012 and the payment rate for a single CPT code billed under
the PFS was not possible. Therefore, for purposes of the analysis, we
examined the difference between the nonfacility payment rates and the
facility payment rates under the PFS for CPT codes 99213 and 99214,
which were the billing codes for a Level III and a Level IV office
visit. Although we did not have data to precisely determine the
equivalent set of PFS visit codes to use for the comparison, we
believed that, based on the distribution of services billed for the
visit codes under the PFS and the distribution of the visit codes under
the OPPS from the last time period the CPT codes were used under the
OPPS in CY 2014, those two codes provided reliable points of
comparison. For CPT code 99213, the difference between the nonfacility
payment rate and the facility payment rate under the PFS in CY 2016 was
$21.86, which was 21 percent of the OPPS payment rate for APC 5012 of
$102.12. For CPT code 99214, the difference between the nonfacility
payment rate and the facility payment rate under the PFS in CY 2016 was
$29.02, which was 28 percent of the OPPS payment rate for APC 5012.
However, we recognized that, due to the more extensive packaging that
occurred under the OPPS for services provided along with clinic visits
relative to the more limited packaging that occurred under the PFS for
office visits, those payment rates were not entirely comparable.
We then assessed the next 24 major codes most frequently billed on
the 13X claim form by hospitals. We removed HCPCS code 36591
(Collection of blood specimen from a completely implantable venous
access device) because, under current PFS policies, the code is used
only to pay separately under the PFS when no other service was on the
claim. We also removed HCPCS code G0009 (Administration of Pneumococcal
Vaccine) because there was no payment for the code under the PFS. For
the remaining 22 major codes most frequently billed, we estimated the
amount that would have been paid to the physician in the office setting
under the PFS for practice expenses not associated with the
professional component of the service. As indicated in Table 9, this
amount reflected (1) the difference between the PFS nonfacility payment
rate and the PFS facility rate, (2) the technical component, or (3) in
instances where payment would have been made only to the facility or
only to the physician, the full nonfacility rate. This estimate ranged
from zero percent to 137.8 percent of the OPPS payment rate for a code.
Overall, the average (weighted by claim line volume times rate) of the
nonfacility payment rate estimate for the PFS compared to the estimate
for the OPPS for the 22 remaining major codes was 45 percent.
Table 9--Comparison of CY 2016 OPPS Payment Rate to CY 2016 PFS Payment Rate for Top Hospital Codes Billed Using
the ``PO'' Modifier
----------------------------------------------------------------------------------------------------------------
CY 2016
applicable
CY 2016 PFS Col (5) as
HCPCS code Code description Total claim OPPS technical a percent PFS estimate
lines payment payment of OPPS
rate amount
estimate
(1) (2)................ (3) (4) (5) (6)
----------------------------------------------------------------------------------------------------------------
96372............. Injection beneath 338,444 $42.31 $25.42 60.1 Single rate paid
the skin or into exclusively to
muscle for either
therapy, practitioner or
diagnosis, or facility: Full
prevention. nonfacility rate.
71020............. X-ray of chest, 2 333,203 60.80 16.83 27.7 Technical
views, front and component: Full
side. nonfacility rate.
93005............. Routine 318,099 55.94 8.59 15.4 Technical
electrocardiogram component: Full
(EKG) with tracing nonfacility rate.
using at least 12
leads.
96413............. Infusion of 254,704 280.27 136.41 48.7 Single rate paid
chemotherapy into exclusively to
a vein up to 1 either
hour. practitioner or
facility: Full
nonfacility rate.
93798............. Physician services 203,926 103.92 11.10 10.7 Nonfacility rate--
for outpatient Facility rate.
heart
rehabilitation
with continuous
EKG monitoring per
session.
96375............. Injection of 189,140 42.31 22.56 53.3 Single rate paid
different drug or exclusively to
substance into a either
vein for therapy, practitioner or
diagnosis, or facility: Full
prevention. nonfacility rate.
93306............. Ultrasound 179,840 416.80 165.77 39.8 Technical
examination of component: Full
heart including nonfacility rate.
color-depicted
blood flow rate,
direction, and
valve function.
77080............. Bone density 155,513 100.69 31.15 30.9 Technical
measurement using component: Full
dedicated X-ray nonfacility rate.
machine.
77412............. Radiation treatment 137,241 194.35 267.86 137.8 Technical component
delivery. (Full nonfacility
rate) based on
weighted averages
for the following
PFS codes: G6011;
G6012; G6013; and
G6014.
90853............. Group psychotherapy 123,282 69.65 0.36 0.5 Nonfacility rate--
Facility rate.
96365............. Infusion into a 122,641 173.18 69.82 40.3 Nonfacility rate--
vein for therapy, Facility rate.
prevention, or
diagnosis up to 1
hour.
20610............. Aspiration and/or 106,769 223.76 13.96 6.2 Nonfacility rate--
injection of large Facility rate.
joint or joint
capsule.
11042............. Removal of skin and 99,134 225.55 54.78 24.3 Nonfacility rate--
tissue first 20 sq Facility rate.
cm or less.
[[Page 53022]]
96367............. Infusion into a 98,930 42.31 30.79 72.8 Single rate paid
vein for therapy exclusively to
prevention or either
diagnosis practitioner or
additional facility: Full
sequential nonfacility rate.
infusion up to 1
hour.
93017............. Exercise or drug- 96,312 220.35 39.74 18.0 Technical
induced heart and component: Full
blood vessel nonfacility rate.
stress test with
EKG tracing and
monitoring.
77386............. Radiation therapy 81,925 505.51 347.30 68.7 Technical
delivery. component:
Nonfacility rate
for CPT code G6015
(analogous code
used under the
PFS).
78452............. Nuclear medicine 79,242 1,108.46 412.82 37.2 Technical
study of vessels component: Full
of heart using nonfacility rate.
drugs or exercise--
multiple studies.
74177............. CT scan of abdomen 76,393 347.72 220.20 63.3 Technical
and pelvis with component: Full
contrast. nonfacility rate.
71260............. CT scan chest with 75,052 236.86 167.21 70.6 Technical
contrast. component: Full
nonfacility rate.
71250............. CT scan chest...... 74,570 112.49 129.61 115.2 Technical
component: Full
nonfacility rate.
73030............. X-ray of shoulder, 71,330 60.80 19.33 31.8 Technical
minimum of 2 views. component: Full
nonfacility rate.
90834............. Psychotherapy, 45 70,524 125.04 0.36 0.3 Nonfacility rate--
minutes with Facility rate.
patient and/or
family member.
----------------------------------------------------------------------------------------------------------------
Weighted Average (claim line volume * rate) of the PFS payment compared to OPPS payment for 45%
the 22 major codes:
----------------------------------------------------------------------------------------------------------------
As noted with the clinic visits, we recognized that there were
limitations to our data analysis, including that OPPS payment rates
include the costs of packaged items or services billed with the
separately payable code, and therefore the comparison to rates under
the PFS was not a one-to-one comparison. Also, we included only a
limited number of services, and noted that additional services may have
different patterns than the services described. After considering the
payment differentials for major codes billed by off-campus departments
of hospitals with the ``PO'' modifier and based on the data limitations
of our analysis, we adopted, with some exceptions noted below, a set of
PFS payment rates that were based on a 50 percent PFS Relativity
Adjuster to the OPPS payment rates (inclusive of packaging) for
nonexcepted items and services furnished by nonexcepted off-campus PBDs
in the CY 2017 interim final rule. Generally speaking, we arrived at
the 50 percent PFS Relativity Adjuster by examining the 45 percent
comparison noted above, the ASC payment rate--which was roughly 55
percent of the OPPS payment rate on average--and the payment rate
differential for the large number of OPPS and PFS E/M services, as
described above. We recognized that the equivalent PFS nonfacility
rates may be higher or lower on a code-specific basis than the rates
that result from applying the overall PFS Relativity Adjuster to the
OPPS payment rates on a code-specific basis. However, we believed that,
on the whole, the percentage reduction did not underestimate the
overall relativity between the OPPS and the PFS based on the limited
data that were available. We were concerned, however, that the 50
percent PFS Relativity Adjuster might overestimate PFS nonfacility
payments relative to OPPS payments. For example, if we were able at the
time to sufficiently estimate the effect of the packaging differences
between the OPPS and PFS, we suspected that the equivalent portion of
PFS payments for evaluation and management codes, and for PFS services
on average, would likely have been less than 50 percent for the same
services. We considered the 50 percent PFS Relativity Adjuster for CY
2017 to be a transitional policy until such time that we had more
precise data to better identify and value nonexcepted items and
services furnished by nonexcepted off-campus PBDs and billed by
hospitals.
We established several significant exceptions to the application of
the 50 percent PFS Relativity Adjuster. For example, we did not apply
the 50 percent PFS Relativity Adjuster to services that are currently
paid under the OPPS based on payment rates from other Medicare fee
schedules (including the PFS) on an institutional claim. The items and
services that are assigned status indicator ``A'' in Addendum B to the
CY 2017 OPPS/ASC final rule with comment period (available on the CMS
Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices-Items/CMS-1656-FC.html) continue to be reported on an
institutional claim and paid under the required Medicare fee schedule
such as the PFS, the CLFS, or the Ambulance Fee Schedule without a
payment reduction. Similarly, drugs and biologicals that are separately
payable under the OPPS (identified by status indicator ``G'' or ``K''
in Addendum B to the CY 2017 OPPS/ASC final rule with comment period)
are paid in accordance with section 1847A of the Act (that is,
typically ASP + 6 percent), consistent with payment rules in the
physician office setting. Drugs and biologicals that are
unconditionally packaged under the OPPS and are not separately payable
(that is, those drugs and biologicals assigned status indicator of
``N'' in Addendum B to the CY 2017 OPPS/ASC final rule with comment
period) are bundled into the PFS payment and are not separately paid to
hospitals billing for nonexcepted items and services furnished by
nonexcepted off-campus PBDs. The full range of exceptions and
adjustments to the otherwise applicable OPPS payment rate that were
adopted in the new PFS site-of-service payment rates in the CY 2017
interim final rule can be found on the CMS Web site at https://
www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/
HospitalOutpatientPPS/Downloads/
[[Page 53023]]
CMS-1656-FC-2017-OPPS-Status-Indicator.zip.
All nonexcepted items and services furnished by nonexcepted off-
campus PBDs and billed by a hospital on an institutional claim with
modifier ``PN'' (Nonexcepted service provided at an off-campus,
outpatient, provider-based department of a hospital) are currently paid
under the PFS at the rate established in the CY 2017 interim final
rule. Specifically, nonexcepted off campus PBDs must report modifier
``PN'' on each UB-04 claim line to indicate a nonexcepted item or
service, and otherwise continue to bill as they currently do. Further
billing instructions on the PN modifier can be found in the January
2017 OPPS Quarterly Update (transmittal 3685, Change Request 9930)
released December 22, 2016, available on the CMS Web site at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R3685CP.pdf.
b. PFS Relativity Adjuster
As noted in the CY 2017 interim final rule, we considered the CY
2017 PFS Relativity Adjuster of 50 percent to be a transitional policy
until such time that we had more precise data to better identify and
value nonexcepted items and services furnished by nonexcepted off-
campus PBDs and billed by hospitals. At present, we do not have more
precise data than were available when we established the PFS Relativity
Adjuster in the CY 2017 interim final rule, and we do not anticipate
having such data until after the end of CY 2017, at the earliest.
However, in developing a policy for CY 2018, we have continued to
explore options for modifying the calculation of the CY 2018 PFS
Relativity Adjuster.
There is no consensus among stakeholders regarding the appropriate
PFS Relativity Adjuster. Many stakeholders have suggested that making
separate facility fee payments to hospitals under the PFS for all
services that are separately paid under the OPPS itself undermines site
neutral payment because practitioners are only paid a single combined
fee for many services when furnished in an office setting, while there
are two separate fees (professional and facility) paid when the service
is furnished in the hospital setting. We acknowledge that there are
many cases where single fees are paid to practitioners for services
furnished in an office setting while fees for comparable services when
furnished in the hospital setting are paid to both the professional and
facility entities. However, we do not agree that this necessarily means
that overall payment cannot be site neutral. We point out that the sum
of the professional and the facility portions of payment for a service
furnished in a nonexcepted off-campus PBD or in a different
institutional setting could be equivalent to a single fee paid to the
professional in the office setting. In the case of some services, in
fact, the single payment made under the PFS at the nonfacility rate
exceeds the sum of the separate payments Medicare makes to the
professional at the facility rate under the PFS and to the facility
under the OPPS. We also note that there are many separately reportable
services under the PFS (for example, the vast majority of services
described by add-on codes) for which separate payment is made to
physician offices but no separate payment is made under either the OPPS
or under the site-specific PFS payments made to hospitals billing for
nonexcepted items and services furnished by nonexcepted off-campus
PBDs. For these reasons, we believe that the overall total payment made
for services is more relevant to the goal of site neutrality than the
quantity of individual payments made. Nonetheless, we continue to
recognize and share stakeholders' concerns regarding the importance of
equivalent overall payment for services, regardless of setting.
In considering the appropriate PFS Relativity Adjuster for CY 2018,
we continue to believe that claims data from CY 2017, which are not yet
available, are needed to guide potential changes to our general
approach. In the absence of such data, however, we have continued to
consider the appropriate PFS Relativity Adjuster based on the
information that is available. In the analysis we used to establish the
PFS Relativity Adjuster for CY 2017, we attempted to identify the
appropriate value by comparing OPPS and PFS payment rates for services
frequently reported in off-campus departments of a hospital and
described by the same codes under the two payment systems. As we
acknowledged in the CY 2017 interim final rule, that data analysis did
not include the most frequently billed service furnished in off-campus
departments of a hospital, outpatient clinic visits. Outpatient clinic
visits are reported using a single G-code under the OPPS and by one of
ten different codes under the PFS.
Consistent with our previously stated concern that the PFS
Relativity Adjuster for CY 2017 might be too small, generally resulting
in greater overall payments to hospitals for services furnished by
nonexcepted off-campus PBDs than would otherwise be paid under the PFS
in the non-facility setting, we believed it was appropriate to propose
changing the PFS Relativity Adjuster in order to ensure that payment
made to these nonexcepted off-campus PBDs better aligns with these
services that are the most frequently furnished in this setting.
In the CY 2018 PFS proposed rule, we proposed to revise the PFS
Relativity Adjuster for nonexcepted items and services furnished by
nonexcepted off-campus PBDs to be 25 percent of the OPPS payment rate.
We arrived at this PFS Relativity Adjuster by making a code-level
comparison for the service most commonly billed in the off-campus PBD
setting under the OPPS: A clinic visit reported using HCPCS code G0463.
In order to determine the analogous payment for the technical aspects
of this service under the PFS in nonfacility settings, we compared the
CY 2017 OPPS national payment rate for HCPCS code G0463 ($102.12) to
the difference between the nonfacility and facility PFS payment amounts
under the PFS using CY 2016 rates for the weighted average of
outpatient visits (CPT codes 99201-99205 and CPT codes 99211-99215)
billed by physicians and other professionals in an outpatient hospital
department as the place of service.
The proposed PFS Relativity Adjuster of 25 percent was based solely
on the comparison for the single service that reflects more than 50
percent of services billed in off-campus PBDs. We continue to recognize
that the comparison between the OPPS and PFS rates for other services
varies greatly, and that there are other factors, including the
specific mix of services furnished by nonexcepted off-campus PBDs,
policies related to packaging of codes under OPPS, and payment
adjustments like MPPRs and bundling under the PFS that rely on
empirical information about whether or not codes are billed on the same
day, that contribute to the differences in aggregate payment amounts
for a broader range of services. However, for CY 2018, as for CY 2017,
we are setting the PFS Relativity Adjuster using currently available
data from CY 2016 because we have not had the opportunity to study the
CY 2017 claims data that may allow us to consider and incorporate many
more factors, including the ones stated above. When we established the
PFS Relativity Adjuster for CY 2017 at 50 percent, we stated that we
did so with the goal of ensuring adequate payment but remained
concerned that the resulting reduction was too conservative. For CY
2018, we were focused on ensuring that we did not overestimate the
appropriate overall payment relativity for these nonexcepted items and
services. Until
[[Page 53024]]
we are able to analyze the CY 2017 claims data, we believed that the
comparison between PFS and OPPS payment for the most common services
furnished in off-campus PBDs, an outpatient clinic visit, was a better
proxy to base the adjuster than our previous approach.
We welcomed stakeholder input with regard to this analysis and the
resulting PFS Relativity Adjuster. We also requested comment on whether
we should adopt a different PFS Relativity Adjuster, such as 40
percent, that represents a relative middle ground between the CY 2017
PFS Relativity Adjuster, selected to ensure adequate payment to
hospitals and our proposed CY 2018 PFS Relativity Adjuster, selected to
ensure that hospitals are not paid more than others would be paid
through the PFS nonfacility rate. We intend to continue to study this
issue and welcomed comments regarding potential future refinements to
payment rates for nonexcepted items and services furnished by
nonexcepted off-campus PBDs as we gain more experience with these new
site-of-service PFS rates.
Finally, we noted that for CY 2018, as in recent years, the annual
update to OPPS payments exceeds the annual update to PFS payments.
Because we proposed to make a single, across-the-board and, by
necessity, imprecise adjustment to OPPS payment rates to establish PFS
payment rates for nonexcepted items and services furnished by
nonexcepted off-campus PBDs, we expected that the actual difference
between OPPS and PFS payment rates for nonexcepted items and services
furnished by nonexcepted off-campus PBDs falls in a range which
includes our proposed PFS Relativity Adjuster (that is, the actual
differential may differ from our proposed PFS Relativity Adjuster). As
such, taking into account the differential between the OPPS and PFS
annual updates by making an adjustment to the PFS Relativity Adjuster,
our proposal for CY 2018 presumed a level of precision in our estimates
that is simply not present in our analysis. Therefore, we did not
adjust our proposal to reflect the relative updates to PFS and OPPS
between CY 2017 and CY 2018, and instead noted that the differential
between the OPPS and PFS payment update for CY 2018 is a factor that
suggests that the PFS Relativity Adjuster may underestimate PFS
nonfacility payment relative to OPPS payments; in future years, we
intend to more precisely account for any differential between these two
update factors.
c. Geographic Adjustments
For CY 2017, we established class-specific geographic practice cost
indices (GPCIs) under the PFS exclusively used to adjust these site-
specific, technical component rates for nonexcepted items and services
furnished in nonexcepted off-campus PBDs. These class-specific GPCIs
are parallel to the geographic adjustments made under the OPPS based on
the hospital wage index. We believed it was appropriate to adopt the
hospital wage index areas for purposes of geographic adjustment because
nonexcepted off-campus PBDs are still considered to be part of a
hospital, and the PFS payments to these entities will be limited to the
subset of PFS services furnished by hospitals. We also believed it was
appropriate, as an initial matter for CY 2017, to adopt the actual wage
index values for these hospitals in addition to the wage index areas.
The PFS GPCIs that would otherwise currently apply are not based on the
hospital wage index areas. For CY 2018, we proposed to continue using
the authority under section 1848(e)(1)(B) of the Act to maintain a
class-specific set of GPCIs for these site-specific technical component
rates that are based both on the hospital wage index areas and the
hospital wage index value themselves. For purposes of payment to
hospitals, this means that the geographic adjustments used under the
OPPS continue to apply.
d. Coding Consistency
For most services, the same HCPCS codes are used to describe
services paid under both the PFS and the OPPS. There are two notable
exceptions that describe high-volume services. The first is the set of
codes that describe evaluation and management (E/M) services which are
reported under the PFS using the 5 levels of CPT codes describing new
or established patient visits (for a total of 10 codes). However, since
CY 2014, these visits have been reported under the OPPS using the
single HCPCS code G0463 (Hospital Outpatient Clinic Visit) (see 78 FR
75042). We proposed to maintain the current coding and PFS payment rate
for HCPCS code G0463 based on the OPPS payment rate modified by the PFS
Relativity Adjuster.
The second exception is a set of radiation treatment delivery and
imaging guidance services that are reported using different codes under
the PFS and the OPPS. CMS established HCPCS Level II G-codes to
describe radiation treatment delivery services when furnished in the
physician office setting (see 79 FR 67666 through 67667). However,
these HCPCS G-codes are not recognized under the OPPS; rather, CPT
codes are used to describe these services when furnished in the HOPD.
Both sets of codes were implemented for CY 2015 and were maintained for
CY 2016. Under the PFS, there is a statutory provision under section
1848(c)(2)(K) of the Act that requires maintenance of the CY 2016
coding and payment inputs for these services for CY 2017 and also for
CY 2018. Accordingly, the CY 2018 PFS rates for these services are
calculated based on the maintenance of the CY 2016 coding and payment
inputs. Because nonexcepted items and services furnished by a
nonexcepted off-campus PBD are paid under the PFS starting in CY 2017,
and we are required to maintain the CY 2016 coding and payment inputs
for these services under the CY 2018 PFS, we proposed to maintain
coding and payment amounts for nonexcepted items and services furnished
by a nonexcepted off-campus PBD consistent with the payments that would
be made to other facilities under the PFS. That is, nonexcepted off-
campus PBDs submitting claims for these nonexcepted items and services
will continue to bill the HCPCS G-codes established under the PFS to
describe radiation treatment delivery services. Under this proposal,
the nonexcepted off-campus PBD must append modifier ``PN'' to each
applicable claim line for these nonexcepted items and services, even
though the PFS Relativity Adjuster will not apply, on the institutional
claim. The payment amount for these services would be set to reflect
the technical component rate for the code under the PFS.
4. OPPS Payment Adjustments
In the CY 2017 interim final rule, we adopted the packaging payment
rates and MPPR percentage that applied under the OPPS to establish the
PFS payment rates for nonexcepted items and services furnished by
nonexcepted off-campus PBDs and billed by hospitals. That is, the
claims processing logic that was used for payments under the OPPS for
comprehensive APCs (C-APCs), conditionally and unconditionally packaged
items and services, and major procedures, was incorporated into the
newly established PFS rates. We continue to believe it is necessary to
incorporate the OPPS payment policies for C-APCs, packaged items and
services, and the MPPR in order to maintain the integrity of the PFS
Relativity Adjuster because the adjuster is intended, in part, to
account for the methodological differences between the OPPS and the PFS
rates that would otherwise apply. We also
[[Page 53025]]
direct interested stakeholders to related policies under the OPPS,
since prospective changes in the applicable adjustments and policies
would generally apply to nonexcepted items and services furnished by
nonexcepted off-campus PBDs for CY 2018. We were interested in comments
regarding the applicability of particular prospective OPPS adjustments
to nonexcepted items and services.
In order to apply these OPPS payment policies and adjustments to
nonexcepted items and services, we proposed that hospitals continue to
bill on an institutional claim form that will pass through the
Outpatient Code Editor and into the OPPS PRICER for calculation of
payment. This approach will yield data based on claims for nonexcepted
items and services furnished by nonexcepted off-campus PBDs, which can
be used to refine PFS payment rates for these services in future years.
There were several OPPS payment adjustments that we did not adopt
in the CY 2017 interim final rule, including, but not limited to,
outlier payments, the rural sole community hospital (SCH) adjustment,
the cancer hospital adjustments, transitional outpatient payments, the
hospital outpatient quality reporting payment adjustment, and the
inpatient hospital deductible cap to the cost-sharing liability for a
single hospital outpatient service. We believed these payment
adjustments were expressly authorized for, and should be limited to,
hospitals that are paid under the OPPS for covered OPD services in
accordance with section 1833(t) of the Act. We believed that these
policies should not apply to nonexcepted items and services furnished
by nonexcepted off-campus PBDs, and did not propose that they apply for
CY 2018.
5. Partial Hospitalization Services
For partial hospitalization programs (PHP), which are intensive
outpatient psychiatric day treatment programs furnished to patients as
an alternative to inpatient psychiatric hospitalization or as a
stepdown to shorten an inpatient stay and transition a patient to a
less intensive level of care, section 1861(ff)(3)(A) of the Act
specifies that a PHP is a program furnished by a hospital, to its
outpatients, or by a Community Mental Health Center (CMHC). In the CY
2017 OPPS/ASC proposed rule (81 FR 45690), in the discussion of the
proposed implementation of section 603 of Bipartisan Budget Act of
2015, we noted that because CMHCs also furnish PHP services and are
ineligible to be provider-based to a hospital, a nonexcepted off-campus
PBD would be eligible for PHP payment if the entity enrolls and bills
as a CMHC for payment under the OPPS. We further noted that a hospital
may choose to enroll a nonexcepted off-campus PBD as a CMHC, provided
it meets all Medicare requirements and conditions of participation.
Commenters expressed concern that without a clear payment mechanism
for PHP services furnished by nonexcepted off-campus PBDs, access to
partial hospitalization services would be limited, and pointed out the
critical role PHPs play in the continuum of mental health care. Many
commenters believed that Congress did not intend for partial
hospitalization services to no longer be paid for by Medicare when such
services are furnished by nonexcepted off-campus PBDs. Several
commenters disagreed with the notion of enrolling as a CMHC in order to
receive payment for PHP services. These commenters stated that
hospital-based PHPs and CMHCs are inherently different in structure,
operation, and payment, and noted that the conditions of participation
for hospital departments and CMHCs are different. Several commenters
requested that CMS find a mechanism to pay hospital-based PHPs in
nonexcepted off-campus PBDs.
Because we shared the commenters' concerns, in the CY 2017 OPPS/ASC
final rule with comment period and interim final rule with comment
period (81 FR 79715, 79717, and 79727), we adopted payment for partial
hospitalization items and services furnished by nonexcepted off-campus
PBDs under the PFS. When billed in accordance with the CY 2017 interim
final rule, these partial hospitalization services are paid at the CMHC
per diem rate for APC 5853, for providing three or more partial
hospitalization services per day (81 FR 79727).
In the CY 2017 OPPS/ASC proposed rule (81 FR 45681), the CY 2017
OPPS/ASC final rule with comment period, and interim final rule with
comment period (81 FR 79717 and 79727), we noted that when a
beneficiary receives outpatient services in an off-campus department of
a hospital, the total Medicare payment for those services is generally
higher than when those same services are provided in a physician's
office. Similarly, when partial hospitalization services are provided
in a hospital-based PHP, Medicare pays more than when those same
services are provided by a CMHC. Our rationale for adopting the CMHC
per diem rate for APC 5853 as the PFS payment amount for nonexcepted
off-campus PBDs providing PHP services is because CMHCs are
freestanding entities that are not part of a hospital, but they provide
the same PHP services as hospital-based PHPs (81 FR 79727). This is
similar to the differences between freestanding entities paid under the
PFS that furnish other services also provided by hospital-based
entities. Similar to other entities currently paid for their technical
component services under the PFS, we believe CMHCs would typically have
lower cost structures than hospital-based PHPs, largely due to lower
overhead costs and other indirect costs such as administration,
personnel, and security. We believe that paying for nonexcepted
hospital-based partial hospitalization services at the lower CMHC per
diem rate aligns with section 603 of Bipartisan Budget Act of 2015,
while also preserving access to PHP services. In addition, nonexcepted
off-campus PBDs will not be required to enroll as CMHCs in order to
bill and be paid for providing partial hospitalization services.
However, a nonexcepted off-campus PBD that wishes to provide PHP
services may still enroll as a CMHC if it chooses to do so and meets
the relevant requirements. Finally, we recognize that because hospital-
based PHPs are providing partial hospitalization services in the
hospital outpatient setting, they can offer benefits that CMHCs do not
have, such as an easier patient transition to and from inpatient care,
and easier sharing of health information between the PHP and the
inpatient staff.
In the CY 2018 PFS proposed rule, we did not propose to require
these PHPs to enroll as CMHCs but instead we proposed to continue to
pay nonexcepted off-campus PBDs providing PHP items and services under
the PFS. Further, in that CY 2018 PFS proposed rule, we proposed to
continue to adopt the CMHC per diem rate for APC 5853 as the PFS
payment amount for nonexcepted off-campus PBDs providing three or more
PHP services per day in CY 2018.
The following is a summary of the public comments received on
potential changes to our methodology and our responses:
Comment: We received several comments in response to the CY 2018
PFS proposals pertaining to nonexcepted off-campus PBDs providing PHP
services. Many of the commenters believed that paying nonexcepted off-
campus PBDs providing PHP services at the CMHC per diem rate does not
compensate enough for financial viability and would jeopardize access
to critically needed mental health services. Other
[[Page 53026]]
commenters were concerned that the payment rate under section 603 of
the Bipartisan Budget Act of 2015 or the lower CMHC payment rate would
affect access by hindering needed expansion of PHPs or limiting the
ability of PHPs to address the growing substance abuse/opioid crisis.
One commenter stated that now is not the time to reduce resources and
treatments for behavioral health, and expressed concern that payment
reductions could push some behavioral health care providers beyond the
point of financial viability. One commenter suggested that the proposed
cuts could force outpatients requiring intensive services, like
beneficiaries in PHPs, back into the inpatient setting.
One commenter had concerns about the accuracy and stability of the
CMHC claims data or CMHC rates, and asked for fair and equitable
payments. A few commenters suggested alternatives, such as exempting
PHP APC codes from section 603 of the Bipartisan Budget Act of 2015
entirely, researching other payment methods, or paying at the hospital-
based PHP rate.
Response: We believe that the CMHC per diem rate provides
appropriate payment for partial hospitalization services. In the CY
2017 OPPS/ASC proposed rule (81 FR 45681) and earlier in this section
of this CY 2018 MPFS final rule, we noted that when a beneficiary
receives services in an excepted off-campus PBD, the Medicare payment
for those services is generally higher than when those same services
are provided in a physician's office. Similarly, when partial
hospitalization services are provided in a hospital-based PHP, Medicare
pays more than when those same services are provided by a CMHC. CMHCs
are freestanding providers that are not part of a hospital, and that
have lower cost structures than hospital-based PHPs. This is similar to
the differences between freestanding entities paid under the MPFS that
furnish other services also provided by hospital-based entities. We
believe that the cost structure for nonexcepted off-campus PBDs
providing PHP items and services is similar to CMHCs. We continue to
believe that paying for nonexcepted hospital-based partial
hospitalization services at the lower CMHC per diem rate is in
alignment with section 603 of Bipartisan Budget Act of 2015 and results
in fair and equitable payments, while also preserving access to the PHP
benefit. As such, we do not believe that the lower CMHC payments made
to nonexcepted off-campus PBDs providing PHP services would result in
these PHP patients being shifted into inpatient care.
Regarding the comment about the accuracy of CMHC claims and rates,
we refer readers to the CY 2016 OPPS/ASC final rule with comment period
(80 FR 70462 through 70466) and the CY 2017 OPPS/ASC final rule with
comment period (81 FR 79680 through 79686) for details on the
ratesetting methodology, including policies that we believe result in
stable and accurate PHP payment rates. Furthermore, we note that the
final CY 2018 CMHC per diem rate is higher than that proposed in the CY
2018 OPPS/ASC proposed rule (82 FR 33639). The final CY 2018 CMHC per
diem rate is 68.8 percent of the final CY 2018 hospital-based PHP per
diem rate under the OPPS (see the CY 2018 OPPS/ASC final rule with
comment period for details). This is a significantly higher percentage
of payment than was proposed for most other items or services provided
in nonexcepted off-campus PBDs that derive their payment amount from CY
2018 OPPS APC rates, and we believe it will help to address commenters'
concerns about ensuring access to valuable PHP services.
In response to the alternatives that commenters suggested, we are
unable to pay nonexcepted off-campus PBDs that are PHPs at the same
rate that hospital-based PHPs are paid under the OPPS or to exempt PHP
APC codes from the requirements of section 603 of the Bipartisan Budget
Act of 2015 because doing so would not meet the requirements of the
amendments made by section 603 of the Bipartisan Budget Act of 2015.
Regarding the comment about considering other payment methodologies for
PHP services, we will take these comments under advisement in
considering whether to propose a different methodology for PHP services
in future rulemaking.
In summary, after considering the public comments, we are
finalizing our proposals as proposed. Therefore, in CY 2018, we are
identifying the PFS as the applicable payment system for PHP services
furnished by a nonexcepted off campus PBDs, and we are setting the PFS
payment rate for these PHP services as the per diem rate that would be
paid to a CMHC in CY 2018.
6. Supervision Rules
The supervision rules that apply for hospitals continue to apply
for nonexcepted off-campus PBDs that furnish nonexcepted items and
services. The amendments made by section 603 of the Bipartisan Budget
Act of 2015 did not change the status of these PBDs, only the status
of, and payment mechanism for, the services they furnish. These
supervision requirements are specified in Sec. 410.27.
7. Beneficiary Cost-Sharing
Under the PFS, the beneficiary copayment is generally 20 percent of
the fee schedule amount, unless there is an applicable exception in
accordance with the statute. All cost-sharing rules that apply under
the PFS in accordance with section 1848(g) of the Act and section
1866(a)(2)(A) of the Act continue to apply for all nonexcepted items
and services furnished by nonexcepted off-campus PBDs, regardless of
the cost-sharing obligation under the OPPS.
8. CY 2019 and Future Years
We continue to believe the amendments made to the statute by
section 603 of the Bipartisan Budget Act of 2015 intended to eliminate
the Medicare payment incentive for hospitals to purchase physician
offices, convert them to off-campus PBDs, and bill under the OPPS for
items and services they furnish there. Therefore, we continue to
believe the payment policy under this provision should ultimately
equalize payment rates between nonexcepted off-campus PBDs and
physician offices to the greatest extent possible, while allowing
nonexcepted off-campus PBDs to bill in a straight-forward way for
services they furnish.
We note that a full year of claims data regarding the mix of
services reported using the ``PN'' modifier (from CY 2017) will first
be available for use in PFS ratesetting for CY 2019. Under the current
methodology, we would expect to use that data in order to ensure that
Medicare payment to hospitals billing for nonexcepted items and
services furnished by nonexcepted off-campus PBDs under the PFS would
reflect the relative resources involved in furnishing the items and
services relative to other PFS services. We recognize that under our
current approach, payment rates would not be equal on a procedure-by-
procedure basis. However, the application of the PFS Relativity
Adjuster would move toward equalizing payment rates in the aggregate
between physician offices and nonexcepted off-campus PBDs to the extent
appropriate. Therefore, for certain specialties, service lines, and
nonexcepted off-campus PBD types, total Medicare payments for the same
services might be either higher or lower when furnished by a
nonexcepted off-campus PBD rather than in a physician office.
Depending on the mix of services for particular off-campus PBDs, we
remain concerned that such specialty-specific patterns in payment
differentials could result in continued incentives for hospitals to buy
certain types of
[[Page 53027]]
physician offices and convert them to excepted off-campus PBDs; these
are the incentives we believe Congress intended to avoid. However,
continuing a policy similar to the one we proposed in the proposed rule
would allow hospitals to continue billing through a facility claim form
and would allow for continuation of the packaging rules and cost
report-based relative payment rate determinations under OPPS, which we
believe are preferable to using the current valuation methodologies
under the PFS that are not well-suited for nonexcepted items and
services furnished by nonexcepted off-campus PBDs. Therefore, for CY
2019 and for future years, we intend to examine the claims data in
order to determine not only the appropriate PFS Relativity Adjuster(s),
but also to determine whether additional adjustments to the methodology
are appropriate--especially with the goal of attaining site neutral
payments to promote a level playing field under Medicare between
physician office settings and nonexcepted off-campus PBD settings,
without regard to the kinds of services furnished by particular off-
campus PBDs. We solicited comments on potential changes to our
methodology that would better account for these specialty-specific
patterns.
The following is a summary of the public comments received on the
potential changes to our methodology and the PFS Relativity Adjuster.
Comment: We received many comments from stakeholders opposing our
proposal to reduce the PFS Relativity Adjuster to 25 percent. The
majority of commenters questioned why CMS would propose a different PFS
Relativity Adjuster for CY 2018 than is currently in place for CY 2017
given the absence of any additional data to inform a more precise
estimate. A number of commenters, including MedPAC, also mentioned the
large variation in the rate differential between the PFS and the OPPS
across the top 22 services, and stated that a PFS Relativity Adjuster
calculated from a single outpatient clinic visit does not represent the
mix of services provided by PBDs.
In addition, several commenters stated their concern that CMS's
approach in developing the PFS Relativity Adjuster fails to account for
the extensive packaging that occurs for outpatient clinic visits
(billed using HCPCS code G0463 under the OPPS) and other common
services. They stated that additional services are often provided with
a single code, and that the PFS Relativity Adjuster does not account
for the resources required to furnish these additional services. They
note that CMS does not account for packaging that occurs under the
OPPS, despite recognizing the importance of such differences between
the payment systems. Some commenters offered their own estimates of the
value of packaging that occurs under the OPPS for the top 22 HCPCS
codes and provided suggestions for incorporating those estimates into
our analysis.
Response: We agree with the commenters' concerns about the proposed
change to the PFS Relativity Adjuster for CY 2018, specifically that
the single code level comparison of the service most commonly billed in
the off-campus setting under the OPPS doesn't adequately reflect the
large variation in services furnished in off-campus PBDs. Furthermore,
we recognize the possibility that our proposed PFS Relativity Adjuster
of 25 percent may overcorrect for the possibility that the CY 2017 PFS
Relativity Adjuster of 50 percent was an overestimate of the relativity
between the OPPS and PFS. We also agree with commenters who stressed
the need to account for packaging rules that apply under the OPPS.
However, we have clearly outlined the challenges we face in calibrating
the PFS Relativity Rate to account for the effect of packaging.
After consideration of the public comments, we believe that an
approach in which we integrate the code-level comparison for the
service most commonly billed in the off-campus PBD setting under the
OPPS (a clinic visit reported using HCPCS code G0463), which was the
basis of our proposed PFS Relativity Adjuster for CY 2018 of 25
percent, with the comparison of relative PFS to OPPS rates for the top
25 (most frequently billed) major codes, which was the basis of our PFS
Relativity Adjuster for CY 2017 of 50 percent, addresses many of the
concerns and comments we received.
For this approach, we updated the list of the 25 major codes billed
by off-campus hospital departments using the ``PO'' modifier to reflect
a full year of claims data for CY 2016 (see Table 10). We did not
exclude HCPCS code G0463 from the analysis, but we retained all other
parameters that we described in the CY 2017 interim final rule,
including the exclusion of separately payable drugs and biologics,
services assigned an OPPS status indicator ``A''. We removed HCPCS code
36591 (Collection of blood specimen from a completely implantable
venous access device) because, under PFS policies, the code is used
only to pay separately under the PFS when no other service was on the
claim. We also removed HCPCS code G0009 (Administration of Pneumococcal
Vaccine) and HCPCS code G0008 (Administration of influenza vaccine)
because there is no payment for these codes under the PFS. Two of these
codes, CPT 36591 and HCPCS G0009, were also removed from our
calculation of the top major codes when we calculated the PFS
Relativity Adjuster in the CY 2017 interim final rule. HCPCS code G0008
was not on the list of the top major codes when we initially analyzed
claims data for CY 2016 available through August 26, 2016, but it
appears on the list of the top codes that contained a ``PO'' modifier
when we analyzed the same data through the end of CY 2016.
We determined the analogous payment for each of the top major HCPCS
codes, including HCPCS code G0463, using the same logic that we applied
in our calculation of the top 22 codes for the CY 2017 interim final
rule. Table 10 shows data for the OPPS rates, the analogous PFS rates,
and the full year utilization for these codes. The resulting
utilization-weighted average comparison between the PFS and the OPPS
for the top 22 codes, following the approach described above, is 35
percent. In other words, on average, the applicable payment amount
under the PFS is 35 percent of the amount that would have been paid
under the OPPS.
In the CY 2018 PFS proposed rule, we sought comment on whether a
different PFS Relativity Adjuster, such as 40 percent, would reflect a
middle ground between the CY 2017 PFS Relativity Adjuster of 50
percent, selected to ensure adequate payment to hospitals, and our
proposed CY 2018 PFS Relativity Adjuster of 25 percent, selected to
ensure that hospitals are not paid more than others would be paid
through the PFS nonfacility rate. Since, as we acknowledged in response
to public comments, we are unable at this time to fully calculate the
effects of packaging under the OPPS, we believe that a 40 percent PFS
Relativity Adjuster, which is an upward adjustment to the 35 percent
calculation described above, is appropriate. We are, therefore,
finalizing a PFS Relativity Adjuster of 40 percent for CY 2018.
Comment: Several commenters requested clarification with regard to
payment for drugs that are packaged under the OPPS. One commenter
stated its belief that many drugs and biological therapies are not paid
separately under the OPPS and therefore would be subject to the
adjuster in the PBD setting. The commenter suggested that the new Level
I and II drug administration codes conditionally packaged under the
OPPS, as finalized in the OPPS CY 2018, would be subject
[[Page 53028]]
to the PFS Relativity Adjuster. Other commenters requested
clarification regarding how CMS will handle 340B drug payment for
nonexcepted off-campus PBDs under section 603 of the Bipartisan Budget
Act of 2015. One commenter wrote that CMS did not specify whether it
will reduce the payment for 340B drugs furnished in nonexcepted off-
campus PBDs, and that there could be a large payment differential for
these drugs furnished in nonexcepted vs. excepted off-campus PBDs.
Response: We appreciate the commenters' request for clarification.
In prior rulemaking, we established the policy that drugs and
biologicals that are separately payable under the OPPS (identified by
status indicator ``G'' or ``K'' under the OPPS) are paid in accordance
with section 1847A of the Act, consistent with payment rules in the
physician office setting. Drugs and biologicals that are
unconditionally packaged under the OPPS will continue to be packaged
when furnished in a nonexcepted off-campus PBD. Drug administration
services subject to conditional packaging (identified by status
indicator ``Q1'' under the OPPS) will be packaged under the OPPS if the
relevant criteria are met; otherwise they are separately paid. We refer
commenters to the file ``Nonexcepted Items and Services Payment by OPPS
Status Indicator'', available on the CMS Web site under downloads for
the CY 2018 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html, for information about the services, by OPPS status
indicator, which are subject to the PFS Relativity Adjuster. Drugs that
are acquired under the 340B program and furnished by nonexcepted off-
campus PBDs are paid under the PFS and are not subject to the OPPS drug
payment policies. We did not propose to adjust payment for 340B-
acquired drugs in nonexcepted off-campus PBDs in CY 2018 but will be
monitor drug utilization in these PBDs. Please refer to section V.B.7
of the CY 2018 OPPS/ASC final rule with comment for a detailed
discussion of the 340B payment policy.
Comment: Several commenters stated their belief that the
appropriate comparison between the PFS and OPPS for purpose of
determining the PFS Relativity Adjuster is the full PFS nonfacility
rate rather than the difference between the facility and the
nonfacility rate.
Response: We disagree with commenters that the total PFS
nonfacility rate should be used to assess relativity between the PFS
and OPPS. As we have stated previously, the practice expense portion of
the nonfacility rate reflects both direct and indirect costs that would
be incurred by the physician in furnishing the service. The facility
rate reflects the relative resources involved in furnishing the service
in a facility setting, where the billing professional does not incur
practice expense costs because they are incurred by the facility. We
believe the most appropriate code-level comparison between the PFS and
the OPPS would reflect the technical component (TC) of each HCPCS code
under the PFS. However, we do not currently calculate a separate
technical component rate for all HCPCS codes under the PFS--only for
those for which the professional and technical components of the
service are distinct and can be separately billed by two different
practitioners or other suppliers under the PFS. We continue to believe
that, for HCPCS codes for which there is a different payment for
facility and nonfacility settings, it is appropriate to compare the
difference under the PFS between the nonfacility and the facility rate
with the OPPS rate.
Comment: We received a few comments suggesting that the PFS rate
for services should be established as a payment floor for nonexcepted
items and services furnished by nonexcepted off-campus PBDs or,
alternatively, that some items and services should be excluded from the
PFS Relativity Adjuster. A few commenters noted that the reduced rate
from applying the PFS Relativity Adjuster would be lower, for certain
services, than what is paid for the technical component for these
services under the PFS. A few commenters specifically cited CPT codes
for PET imaging procedures (CPT codes 78459, 79491, 78492, 78608, and
78811-78816), which are subject to payment policies under the Deficit
Reduction Act (DRA) of 2005.
Response: We appreciate the commenters' concerns. We recognize that
the PFS payment for some services will be lower or higher, on a code by
code basis, than the PFS payment for nonexcepted items and services
furnished by nonexcepted PBDs calculated using the PFS Relativity
Adjuster. We also recognize that there are certain CPT codes that are
subject to payment rules limiting the payment amount for services. We
will consider whether it would be appropriate to set a floor using the
PFS, or otherwise address codes subject to statutory payment
restrictions, in future rulemaking.
Comment: We received support from several commenters about our
proposal to reduce the PFS Relativity Adjuster to 25 percent.
Generally, the commenters indicated that the proposed rate more
accurately represents the intent of the statute, which is to reduce
financial incentives for hospitals to purchase freestanding physician
practices. Several commenters, including a major national health
insurer, were supportive of efforts in general to establish more
equitable payment across sites of service.
Response: We thank commenters for their support. We are encouraged
by the amount of interest generated in response to the implementation
of section 603 of the Bipartisan Budget Act of 2015. As we stated
above, we were persuaded by commenters that the establishment of the
proposed PFS Relativity Adjuster of 25 percent derived from a single
HCPCS code for outpatient clinic visits may overcorrect for the risk
that the CY 2017 PFS adjuster overstated relativity between the OPPS
and the PFS. We believe that our revised approach, which builds the
relative payment for clinic visits between the PFS and the OPPS into
our prior analysis of the top 22 HCPCS codes, is a more appropriate
approach for payment in CY 2018, in response to these concerns.
Therefore, using such an approach, we are finalizing a PFS Relativity
Adjuster of 40 percent for CY 2018.
Comment: Several commenters pointed out that nonexcepted off-campus
PBDs face higher operational and regulatory costs than freestanding
physician offices, and that intent of the statute could not have been
to equalize payments between nonexcepted off-campus PBDs and
freestanding physician offices.
Response: We do not disagree that there may be additional
regulatory and operational costs faced by off-campus PBDs. However, we
continue to believe that the amendments made to the statute by section
603 of the Bipartisan Budget Act of 2015 are intended to eliminate the
Medicare payment incentive for hospitals to purchase physician offices
and bill under the OPPS for items and services furnished there. We
believe that, by removing the financial incentive for hospitals to
purchase freestanding facilities, we allow market forces to determine
the appropriate number and distribution of hospital PBDs and physician
offices based on regional costs, practice patterns, patient needs.
Comment: We received comments expressing general frustration with
the longstanding differences in payment policies between the PFS and
the OPPS. The commenters stated their belief that the PFS underpays for
the value of services furnished in nonfacility
[[Page 53029]]
settings, thereby driving physicians into hospital employment
agreements. They stated that this general pattern detracts from
developing and implementing more cost efficient models of care.
Moreover, disparate payments between OPPS and PFS drive the creation of
health system monopolies, which generally increase the overall cost of
care for the population and reduce the feasibility of operating
independent physician practices.
Response: We appreciate the perspectives of the commenters. We note
that payments made under the PFS and the OPPS are established under
different statutory authorities using wholly different bases and
methodologies, and therefore often result in differential payment
amounts for similar services. We do not have the legal authority, with
limited exceptions such as section 603 of the Bipartisan Budget Act of
2015, to develop or implement modified payment rates that would broadly
reduce the differences in payment between physician offices and
hospital outpatient departments.
Comment: Many commenters described the importance of hospital off-
campus PBDs in meeting the needs of rural and high risk patients. They
maintained that payments made using the PFS Relativity Adjuster,
particularly at the proposed rate of 25 percent, would be so low as to
prohibit hospitals from providing needed services to high risk
populations and may even require some hospital locations to close. A
commenter specifically requested that CMS conduct an impact assessment
before continuing with implementation of the statute.
Response: We appreciate the comment and understand the
stakeholders' concerns about access to care for rural populations. As
you know, section 603 amended the statute at section 1833(t) of the Act
to carve out certain items and services furnished by certain off-campus
outpatient departments of a provider from the definition of covered
outpatient services, and from payment under the OPPS beginning on
January 1, 2017. We do not believe that section 603 of the Bipartisan
Budget Act of 2015 restricts options for patients in rural and
underserved areas, and moreover, we do not believe the statutory
amendments have been implemented in a manner that restricts access to
care for rural populations.
We have previously stated that we consider the PFS Relativity
Adjuster to be an interim policy until a complete year of claims data
from CY 2017 are available for analysis. Once such data are available,
we expect to calculate and propose a more precise payment rate.
Additionally, we continue to consider options for nonexcepted off-
campus PBDs to bill for nonexcepted items and services using a PFS
claim, effectively allowing us to develop and pay a code-specific
amount representing the technical component of furnishing a service.
Comment: A couple of commenters indicated their belief that CMS is
making drastic changes to payment policies for nonexcepted items and
services furnished by nonexcepted off-campus PBDs and that this
adversely impacts the ability of hospitals and physician offices to
conduct long term planning. One commenter stated that our proposal to
change the PFS Relativity Adjuster for CY 2018 contradicts CMS's
statement in the CY 2017 interim final rule (81 FR 79720 through 79729)
in which we articulated that, unless there are significant changes to
the policies set forth in the interim final rule, we anticipate
continuing to use the same method to determine PFS payment amounts for
nonexcepted items and services furnished by nonexcepted off-campus PBDs
in the near term. Several commenters indicated that they had
interpreted CMS's statements as a promise that the PFS Relativity
Adjuster would remain at 50 percent until such time that we had
required data available to more precise calculation. The commenters,
representing hospital stakeholders, suggested that they may not have
moved forward with planned expansions of new off-campus PBDs if they
had known we would change the PFS Relativity Adjuster.
Response: We thank commenters for their concerns. We do not agree
that our statements in the CY 2017 interim final rule reflected a
promise not to change the PFS Relativity Adjuster over the next two to
three years. Rather, we stated that the general approach, in which we
calculate an overall reduction--the PFS Relativity Adjuster--to
nonexcepted items and services furnished by nonexcepted off-campus PBDs
when billed with a ``PN'' modifier, would remain in place until we were
able to establish code-specific reductions that represent the technical
component of services furnished under the PFS or until we were able to
implement system changes needed to enable nonexcepted off-campus PBDs
to bill for the technical component of nonexcepted items and services
using a professional claim. We are required by law to implement payment
changes for nonexcepted PBDs. Through notice and comment rulemaking in
the CY 2017 interim final rule and the CY 2018 PFS proposed rule, we
have been as transparent as possible in our methodology for determining
the PFS Relativity Adjuster, including limitations related to data
availability. We believe we have given sufficient information about our
underlying concerns and objectives, including the transitory nature of
this payment policy until we have the opportunity to analyze CY 2017
claims data. In addition, while we currently lack both the data and the
infrastructure to require hospitals to bill for nonexcepted items and
services furnished by nonexcepted off-campus PBDs using a professional
claim, we are continuing to explore the changes that would be needed to
do so for future years. This change would allow nonexcepted off-campus
PBDs to report services using the same coding as would be used by
practitioners and suppliers under the PFS and to bill specifically for
nonexcepted items and services at rates that represent the technical
component of services furnished under the PFS.
Comment: Several stakeholders commented on topics related to
policies we addressed in prior rulemaking or policies that are outside
the scope of this final rule. Commenters urged CMS to expand excepted
status of an off-campus PBD that is changing location or ownership.
Other commenters, however, suggested that we remove the excepted status
for off-campus PBDs entirely, even for those billing as a PBD prior to
November 2, 2015.
Response: We appreciate commenters' concerns regarding these
topics. However, we note that the implementation of section 603 of the
Bipartisan Budget Act of 2015 was finalized in the CY 2017 CY OPPS/ASC
final rule with comment period (81 FR 79699 through 79719), and we did
not make any proposals in the CY 2018 PFS proposed rule related to
defining the applicable items and services furnished by certain off-
campus outpatient departments of a provider, which will not be
considered covered OPD services on or after January 1, 2017 (that is,
how we defined nonexcepted items and services furnished by nonexcepted
off-campus PBDs). Thus, comments addressing such issues are outside the
scope of this rulemaking. Comments submitted with technical billing
questions are addressed through applicable program instructions. For
policies related to patient cost sharing under the OPPS and for
guidance related to cost reporting for nonexcepted items and services
furnished by nonexcepted PBDs, we direct commenters to the OPPS CY 2018
final rule.
[[Page 53030]]
Comment: We received several comments questioning why we have not
responded to comments on the CY 2017 OPPS interim final rule in which
we implemented the CY 2017 PFS Relativity Adjuster of 50 percent. The
same commenters also questioned whether our proposal to reduce the PFS
Relativity Adjuster to 25 percent might be a violation of our
rulemaking obligations under the Administrative Procedure Act (APA) (5
U.S.C. 553) insofar as we indicated our intention to develop a revised
PFS relativity adjuster based on claims data when they became
available, and there are not yet claims data available to develop a
more appropriate payment adjustment. Some commenters further suggested
that our policies regarding the PFS relativity adjuster, made in the
absence of specific data to support them as explained in the CY 2017
interim final rule, are arbitrary and capricious.
Response: We appreciate the commenters' concerns about adhering to
the rulemaking requirements of the APA. To meet our rulemaking
obligations, we generally respond to comments on an interim final rule
at the time that we adopt final policies relating to that interim final
rule. On the whole, commenterson the CY 2017 interim final rule who
disagreed with setting the CY 2017 PFS Relativity Adjuster at 50
percent articulated concerns about the approach we used to arrive at
that rate. In particular, commenters highlighted the differences in
packaging rules under the PFS and the OPPS, and suggested that CMS
should use the total nonfacility rate (rather than the nonfacility
minus facility rate) to compare relative payments between PFS and OPPS.
We are currently addressing, through notice and rulemaking for CY 2018,
the concerns raised by commenters and stakeholders related to the
policies that we proposed and are finalizing for CY 2018. However, we
note that the public comments on the CY 2017 interim final rule and on
the CY 2018 PFS proposed rule express many of the same views and
concerns about how we should set the PFS relativity adjuster.
We presented the analysis and reasons that led us to the proposed
PFS Relativity Adjuster of 25 percent for CY 2018; and we responded to
public comments on that proposal with a revised analysis and the final
PFS Relativity Adjuster of 40 percent for CY 2018. We have provided the
data required to replicate our analysis, consistently based upon CY
2016 payment rates under the PFS and OPPS, for the CY 2017 interim
final, and for the proposed and final CY 2018 PFS relativity adjusters.
Furthermore, we have been as transparent as possible in our approach,
including the limitations related to data availability, and our
inability to develop a precise adjustment to the relative payment rates
that would account for differences between the two payment systems,
including packaging. We believe we are moving as judiciously as
possible, given these limitations, to meet the requirements of the
statute, providing public transparency into our policy considerations,
and in full accordance with our notice and comment rulemaking
obligations. We are finalizing a PFS Relativity Adjuster of 40 percent
for CY 2018 as discussed earlier in this section.
Comment: Several commenters requested that CMS move all of the
rulemaking, including requests for comments, comment summaries and our
responses, for policies relating to the implementation of section 603
of the Bipartisan Budget Act of 2015 from the PFS rule to the OPPS
rule. They cited the additional burden of responding to such
interrelated policies in different rules.
Response: We appreciate the commenters' concern about the
challenges presented by addressing policies that implicate two payment
systems that are issued in two separate rulemaking processes. However,
because the policies included in this final rule relate to payments
that are made under the PFS to nonexcepted off-campus PBDs furnishing
nonexcepted items and services, we believe it is appropriate that these
issues be addressed in rulemaking for the PFS. We note that policies
related to interpretation of the OPPS statute will continue to be
addressed in OPPS rulemaking.
Table 10--Comparison of CY 2016 OPPS Payment Rate to CY 2016 PFS Payment Rate for Top Hospital Codes Billed
Using the ``PO'' Modifier
----------------------------------------------------------------------------------------------------------------
CY 2016
applicable
CY 2016 CY 2016 PFS Col (5) as
HCPCS code Code description total claim OPPS technical a PFS estimate
lines payment payment percentage
rate amount of OPPS
estimate
(1) (2)................ (3) (4) (5) (6)
----------------------------------------------------------------------------------------------------------------
G0463............. Hospital outpt 13,835,921 $102.12 $26.71 26.16 Nonfacility rate--
clinic visit. Facility rate
based on the
average of ten PFS
CPT codes: 99201--
99205 and 99211 0
99215.
96372............. Ther/proph/diag inj 725,665 42.31 25.42 60.1 Single rate paid
sc/im. exclusively to
either
practitioner or
facility; full
nonfacility rate.
71020............. Chest x-ray 2vw 719,451 60.80 16.83 27.7 Technical
frontal&latl. component: Full
nonfacility rate.
93005............. Electrocardiogram 662,763 55.94 8.59 15.4 Single rate paid
tracing. exclusively to
either
practitioner or
facility; full
nonfacility rate.
96413............. Chemo iv infusion 1 563,245 280.27 136.41 48.7 Single rate paid
hr. exclusively to
either
practitioner or
facility: Full
nonfacility rate.
93798............. Cardiac rehab/ 448,130 103.92 11.10 10.7 Nonfacility rate--
monitor. Facility rate.
96375............. Tx/pro/dx inj new 408,751 42.31 22.56 53.3 Single rate paid
drug addon. exclusively to
either
practitioner or
facility; full
nonfacility rate.
93306............. Tte w/doppler 369,856 416.80 165.77 39.8 Technical
complete. component: full
nonfacility rate.
77080............. Dxa bone density 344,118 100.69 31.15 30.9 Technical
axial. component: full
nonfacility rate.
90853............. Group psychotherapy 299,446 69.65 0.36 0.5 Nonfacility rate--
Facility rate.
77412............. Radiation treatment 296,601 194.35 266.86 137.3 Technical component
delivery. (Full nonfacility
rate) based on
weighted averages
for the following
PFS codes: G6011;
G6012; G6013; and
G6014.
96365............. Ther/proph/diag iv 269,899 173.18 69.82 40.3 Single rate paid
inf init. exclusively to
either
practitioner or
facility: Full
nonfacility rate.
20610............. Drain/inj joint/ 221,922 223.76 13.96 6.2 Nonfacility rate--
bursa w/o us. Facility rate.
[[Page 53031]]
96367............. Tx/proph/dg addl 217,098 42.31 30.79 72.8 Single rate paid
seq iv inf. exclusively to
either pracitioner
or facility: Full
nonfacility rate.
11042............. Deb subq tissue 20 215,734 225.55 54.78 24.3 Nonfacility rate--
sq cm/<. Facility rate.
93017............. Cardiovascular 196,183 220.35 39.74 18.0 Single rate paid
stress test. exclusively to
either
practitioner or
facility; full
nonfacility rate.
77386............. Ntsty modul rad tx 182,989 505.51 347.30 68.7 Technical
dlvr cplx. component:
Nonfacility rate
for CPT code G6015
(analogous code
used under the
PFS).
74177............. Ct abd & pelv w/ 167,549 347.72 220.20 63.3 Technical
contrast. component: Full
nonfacility rate.
71260............. Ct thorax w/dye.... 163,756 236.86 167.21 70.6 Technical
component: Full
nonfacility rate.
71250............. Ct thorax w/o dye.. 160,956 112.49 129.61 115.2 Technical
component: Full
nonfacility rate.
78452............. Ht muscle image 159,219 1,108.46 412.82 37.2 Technical
spect mult. component: Full
nonfacility rate.
96415............. Chemo iv infusion 151,700 42.31 28.64 67.7 Single rate paid
addl hr. exclusively to
either
practitioner or
facility; full
nonfacility rate.
----------------------------------------------------------------------------------------------------------------
Weighted Average (claim line volume * rate) of the PFS payment compared to OPPS payment for 35%
the 22 major codes:
----------------------------------------------------------------------------------------------------------------
H. Valuation of Specific Codes
1. Background: Process for Valuing New, Revised, and Potentially
Misvalued Codes
Establishing valuations for newly created and revised CPT codes is
a routine part of maintaining the PFS. Since the inception of the PFS,
it has also been a priority to revalue services regularly to make sure
that the payment rates reflect the changing trends in the practice of
medicine and current prices for inputs used in the PE calculations.
Initially, this was accomplished primarily through the 5-year review
process, which resulted in revised work RVUs for CY 1997, CY 2002, CY
2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY
2011. Under the 5-year review process, revisions in RVUs were proposed
and finalized via rulemaking. In addition to the 5-year reviews,
beginning with CY 2009, CMS and the RUC have identified a number of
potentially misvalued codes each year using various identification
screens, as discussed in section II.E.4 of this final rule.
Historically, when we received RUC recommendations, our process had
been to establish interim final RVUs for the potentially misvalued
codes, new codes, and any other codes for which there were coding
changes in the final rule for a year. Then, during the 60-day period
following the publication of the final rule, we accepted public comment
about those valuations. For services furnished during the calendar year
following the publication of interim final rates, we paid for services
based upon the interim final values established in the final rule. In
the final rule with comment period for the subsequent year, we
considered and responded to public comments received on the interim
final values, and typically made any appropriate adjustments and
finalized those values.
In the CY 2015 PFS final rule with comment period, we finalized a
new process for establishing values for new, revised and potentially
misvalued codes. Under the new process, we include proposed values for
these services in the proposed rule, rather than establishing them as
interim final in the final rule with comment period. Beginning with the
CY 2017 PFS proposed rule, the new process was applicable to all codes,
except for new codes that describe truly new services. For CY 2017, we
proposed new values in the CY 2017 PFS proposed rule for the vast
majority of new, revised, and potentially misvalued codes for which we
received complete RUC recommendations by February 10, 2016. To complete
the transition to this new process, for codes for which we established
interim final values in the CY 2016 PFS final rule with comment period,
we reviewed the comments received during the 60-day public comment
period following release of the CY 2016 PFS final rule with comment
period, and re-proposed values for those codes in the CY 2017 PFS
proposed rule.
We considered public comments received during the 60-day public
comment period for the proposed rule before establishing final values
in the CY 2017 PFS final rule. As part of our established process, we
will adopt interim final values only in the case of wholly new services
for which there are no predecessor codes or values and for which we do
not receive recommendations in time to propose values. For CY 2017, we
did not identify any new codes that described such wholly new services.
Therefore, we did not establish any code values on an interim final
basis.
2. Methodology for Establishing Work RVUs
For each code identified in this section, we conducted a review
that included the current work RVU (if any), RUC-recommended work RVU,
intensity, time to furnish the preservice, intraservice, and
postservice activities, as well as other components of the service that
contribute to the value. Our reviews of recommended work RVUs and time
inputs have generally included, but have not been limited to, a review
of information provided by the RUC, the Health Care Professionals
Advisory Committee (HCPAC), and other public commenters, medical
literature, and comparative databases, as well as a comparison with
other codes within the PFS, consultation with other physicians and
health care professionals within CMS and the federal government, as
well as Medicare claims data. We have also assessed the methodology and
data used to develop the recommendations submitted to us by the RUC and
other public commenters and the rationale for the recommendations. In
the CY 2011 PFS final rule with comment period (75 FR 73328 through
73329), we discussed a variety of methodologies and approaches used to
develop work RVUs,
[[Page 53032]]
including survey data, building blocks, crosswalks to key reference or
similar codes, and magnitude estimation (see the CY 2011 PFS final rule
with comment period (75 FR 73328 through 73329) for more information).
When referring to a survey, unless otherwise noted, we mean the surveys
conducted by specialty societies as part of the formal RUC process. We
have used the building block methodology to construct, or deconstruct,
the work RVU for a CPT code based on component pieces of the code.
Components that we have used in the building block approach may
have included preservice, intraservice, or postservice time and post-
procedure visits. When referring to a bundled CPT code, the building
block components could include the CPT codes that make up the bundled
code and the inputs associated with those codes. Magnitude estimation
refers to a methodology for valuing work that determines the
appropriate work RVU for a service by gauging the total amount of work
for that service relative to the work for a similar service across the
PFS without explicitly valuing the components of that work. In addition
to these methodologies, we have frequently utilized an incremental
methodology in which we value a code based upon its incremental
difference between another code and another family of codes. The
statute specifically defines the work component as the resources in
time and intensity required in furnishing the service. Also, the
published literature on valuing work has recognized the key role of
time in overall work. For particular codes, we have refined the work
RVUs in direct proportion to the changes in the best information
regarding the time resources involved in furnishing particular
services, either considering the total time or the intraservice time.
Several years ago, to aid in the development of preservice time
recommendations for new and revised CPT codes, the RUC created
standardized preservice time packages. The packages include preservice
evaluation time, preservice positioning time, and preservice scrub,
dress and wait time. Currently there are preservice time packages for
services typically furnished in the facility setting (for example:
Preservice time packages reflecting the different combinations of
straightforward or difficult procedure, and straightforward or
difficult patient). Currently, there are three preservice time packages
for services typically furnished in the nonfacility setting.
We developed several standard building block methodologies to value
services appropriately when they have common billing patterns. In cases
where a service is typically furnished to a beneficiary on the same day
as an evaluation and management (E/M) service, we believe that there is
overlap between the two services in some of the activities furnished
during the preservice evaluation and postservice time. Our longstanding
adjustments have reflected a broad assumption that at least one-third
of the work time in both the preservice evaluation and postservice
period is duplicative of work furnished during the E/M visit.
Accordingly, in cases where we have believed that the RUC has not
adequately accounted for the overlapping activities in the recommended
work RVU and/or times, we have adjusted the work RVU and/or times to
account for the overlap. The work RVU for a service is the product of
the time involved in furnishing the service multiplied by the intensity
of the work. Preservice evaluation time and postservice time both have
a long-established intensity of work per unit of time (IWPUT) of
0.0224, which means that 1 minute of preservice evaluation or
postservice time equates to 0.0224 of a work RVU.
Therefore, in many cases when we have removed 2 minutes of
preservice time and 2 minutes of postservice time from a procedure to
account for the overlap with the same day E/M service, we have also
removed a work RVU of 0.09 (4 minutes x 0.0224 IWPUT) if we have not
believed the overlap in time had already been accounted for in the work
RVU. The RUC has recognized this valuation policy and, in many cases,
now addresses the overlap in time and work when a service is typically
furnished on the same day as an E/M service.
We note that many commenters and stakeholders have expressed
concerns over time with our ongoing adjustment of work RVUs based on
changes in the best information we have had regarding the time
resources involved in furnishing individual services. We have been
particularly concerned with the RUC's and various specialty societies'
objections to our approach given the significance of their
recommendations to our process for valuing services and since much of
the information we have used to make the adjustments is derived from
their survey process. We are statutorily obligated to consider both
time and intensity in establishing work RVUs for PFS services. As
explained in the CY 2016 PFS final rule with comment period (80 FR
70933), we recognize that adjusting work RVUs for changes in time is
not always a straightforward process, so we have applied various
methodologies to identify several potential work values for individual
codes.
We have observed that for many codes reviewed by the RUC,
recommended work RVUs have appeared to be incongruous with recommended
assumptions regarding the resource costs in time. This has been the
case for a significant portion of codes for which we have recently
established or proposed work RVUs that are based on refinements to the
RUC-recommended values. When we have adjusted work RVUs to account for
significant changes in time, we have begun by looking at the change in
the time in the context of the RUC-recommended work RVU. When the
recommended work RVUs have not appeared to account for significant
changes in time, we have employed the different approaches to identify
potential values that reconcile the recommended work RVUs with the
recommended time values. Many of these methodologies, such as survey
data, building block, crosswalks to key reference or similar codes, and
magnitude estimation have long been used in developing work RVUs under
the PFS. In addition to these, we have sometimes used the relationship
between the old time values and the new time values for particular
services to identify alternative work RVUs based on changes in time
components.
In so doing, rather than ignoring the RUC-recommended value, we
have used the recommended values as a starting reference and then
applied one of these several methodologies to account for the
reductions in time that we believe had not otherwise been reflected in
the RUC-recommended value. When we have believed that such changes in
time have already been accounted for in the RUC recommendation, then we
have not made such adjustments. Likewise, we have not arbitrarily
applied time ratios to current work RVUs to calculate proposed work
RVUs. We have used the ratios to identify potential work RVUs and
considered these work RVUs as potential options relative to the values
developed through other options.
We do not imply that the decrease in time as reflected in survey
values must equate to a one-to-one or linear decrease in newly valued
work RVUs. Instead, we have believed that, since the two components of
work are time and intensity, absent an obvious or explicitly stated
rationale for why the relative intensity of a given procedure has
increased, significant decreases in time should be reflected in
decreases to work RVUs. If the RUC recommendation had appeared to
disregard or dismiss the
[[Page 53033]]
changes in time, without a persuasive explanation of why such a change
should not be accounted for in the overall work of the service, then we
have generally used one of the aforementioned methodologies to identify
potential work RVUs, including the methodologies intended to account
for the changes in the resources involved in furnishing the procedure.
Several stakeholders, including the RUC, in general have objected
to our use of these methodologies and deemed our actions in adjusting
the recommended work RVUs as inappropriate; other stakeholders have
also expressed concerns with CMS refinements to RUC recommended values
in general. In the CY 2017 PFS final rule (81 FR 80272 through 80277)
we responded in detail to several comments that we received regarding
this issue. In the CY 2017 PFS proposed rule, we requested comments
regarding potential alternatives to making adjustments that would
recognize overall estimates of work in the context of changes in the
resource of time for particular services; however, we did not receive
any specific potential alternatives as requested.
In developing proposed values for new, revised, and potentially
misvalued codes for CY 2018, we considered the lack of alternative
approaches to making the adjustments, especially since many
stakeholders have routinely urged us to propose and finalize the RUC-
recommended values. We also considered the RUC's consistent reassurance
that these kinds of concerns (regarding changes in time, for example)
had already been considered, and either incorporated or dismissed, as
part of the development of their recommended values. These have led us
to shift our approach to reviewing RUC recommendations, especially as
we believe that the majority of practitioners paid under the PFS,
though not necessarily those in any particular specialty, would prefer
CMS rely more heavily on RUC recommended values in establishing payment
rates under the PFS.
For CY 2018, we generally proposed the RUC-recommended work RVUs
for new, revised, and potentially misvalued codes. We proposed these
values based on our understanding that the RUC generally considers the
kinds of concerns we have historically raised regarding appropriate
valuation of work RVUs. However, during our review of these recommended
values, we identified some concerns similar to those we have recognized
in prior years. Given the relative nature of the PFS and our obligation
to ensure that the RVUs reflect relative resource use, we included
descriptions of potential approaches we might have taken in developing
work RVUs that differ from the RUC-recommended values. We sought
comment on both the RUC-recommended values as well as the alternatives
considered.
The following is a summary of the public comments received on both
the RUC-recommended values as well as the alternatives we considered in
developing work RVUs and our responses:
Comment: Several commenters generally support the proposed use of
the RUC-recommended work RVUs, without refinement. One commenter
encouraged further collaboration between the RUC and CMS to improve the
relativity within the payment system.
Response: We thank the commenters for their input and support of
the proposals. We also agree that collaboration is a critical element
in our establishment of work RVUs. In our review of work RVUs and time
inputs, we have and will continue to consider information from various
public commenters, medical literature, the HCPAC, information provided
by the RUC, Medicare claims data, and other relevant sources.
Comment: One commenter stated that the RUC thoroughly vets the
times and values of the procedures it reviews, applies the right
valuation methodology to appropriately value the procedures that are
being reviewed, and usually adjusts the times identified by the survey
if the times seem unreasonable. Another commenter stated that
recommendations by the RUC remain the most robust mechanism for
collecting data and establishing relative values. A few commenters
stated that CMS should depend on RUC-recommended values instead of
trying to create an arbitrary, new methodology that lacks reliability
or reflects significantly flawed rationales. A few commenters stated
that CMS work value reductions are done with complete disregard for the
rigorous process conducted by the RUC with input from medical specialty
societies to develop data driven recommendations for physician work
values and without presenting data to support these reductions.
Response: We agree that the RUC provides critically important
information for our review process. However, our review of recommended
work RVUs and time inputs also generally includes review of various
sources, in addition to the RUC, such as information provided by other
public commenters, comparative databases, and medical literature which
are also vital sources of information. We disagree with the commenters
that CMS has created arbitrary, unreliable work value reductions that
have disregarded the RUC process. We have historically used the RUC-
recommended values or existing values as a starting point in our
review, and then applied adjustments as necessary, particularly when we
find that the RUC recommendation does not appropriately account for
recommended changes in time, and provides no explanation as to why this
would be appropriate.
Comment: One commenter expressed disappointment with situations
where CMS rejects recommended work valuations and direct PE inputs that
would have resulted in expenditure decreases, and was concerned that
all professionals are impacted. The commenter stated that CMS should
accept RUC-recommended values and inputs that would result in
expenditure decreases or hold all other healthcare professionals
harmless for the decision to reject them.
Response: We appreciate the commenter's views, but note that we are
required to establish appropriate valuations and ensure that RVUs are
reflective of relative resources involved in furnishing a service. In
reviewing specific codes, we make these decisions the same way
regardless of whether the decisions would result in increases or
decreases to overall expenditures under the PFS. Additionally, we do
not have authority to exempt the rates for particular services from
budget neutrality adjustments, relativity adjustments, or the effects
of the misvalued code target recapture adjustments based on differences
between what the RUC recommends and what CMS finalizes through notice
and comment rulemaking.
Comment: Some commenters expressed concern about the effect of the
misvalued code reviews on particular specialties and settings. The
commenters recommended insulating particular settings or specialties
from the impact of the code reviews.
Response: We are required to periodically review the accuracy of
RVUs for all services furnished under the PFS. We do not believe it
would be appropriate, nor do we have any specific authority, to
insulate particular settings or specialties from the impact of this
review. We also note that most misvalued code reviews and revaluations
are triggered by the identification of codes under the potentially
misvalued code categories that are enumerated in the statute.
[[Page 53034]]
Comment: One commenter stated that it is open to supporting our
alternative methods of valuation if the methods are disclosed and there
is ample time to review, comment, and iterate on suggestions. The
commenter stated that the RUC process currently allows for this.
Another commenter stated that it appreciates CMS providing stakeholders
with discussion of alternative approaches that the agency might have
used to reach a different value, rather than proposing those values.
The commenter stated that this gives specialties an opportunity to
consider the alternative values, while also providing a pathway for us
to finalize an alternative value based on information provided by
stakeholders. The commenter also stated that it believes many of these
alternative methods could be raised during deliberations at RUC
meetings when specialties and their expert physician advisors are
available to engage in a dialogue with CMS representatives. In
addition, the commenter stated that CMS representatives who attend the
RUC meetings should engage more actively in discussion with society
representatives about the agency's issues and concerns with work and
direct PE inputs, rather than first sharing concerns in the proposed
rule when dialogue is restricted due to the rulemaking process.
Response: While the comment period does not provide for an
iterative process as suggested by one of the commenters, it does
provide an opportunity for all interested parties to review and have an
opportunity to comment on the proposals and alternative valuations
considered. While we acknowledge that discussion and consideration of
different valuations occurs during the RUC process, we also note that
not all interested parties have the opportunity to participate in the
RUC process, and not all relevant stakeholders are members of the RUC.
Additionally, we would like to reiterate that, while we appreciate that
some commenters believe that CMS staff could offer useful perspectives
by regularly attending and participating more fully in the RUC
meetings, we do not believe that would be appropriate for many reasons,
not least of which is that CMS staff participation in the RUC process
cannot supplant our obligation to establish through notice and comment
rulemaking what we determine to be appropriate RVUs for each reviewed
code. Accordingly, we disagree with the commenter's suggestion that CMS
staff should preemptively address the concerns of work and PE values
during the RUC meeting, instead of through notice and comment
rulemaking. Formal notice and comment rulemaking allows all interested
parties the opportunity to review our proposals and provide feedback,
as well as to submit supplemental information about our proposals, and
address any concerns or alternatives we have expressed in making our
proposals.
Comment: Several commenters expressed concern and disappointment
with our proposed approach for valuing codes for CY 2018. MedPAC stated
that it believes CMS is moving in the wrong direction by proposing to
accept all of the RUC recommendations for work RVUs for CY 2018 without
modification, and that this approach is inconsistent with MedPAC's
longstanding view that CMS relies too heavily on input from the RUC,
which is made up of practitioners who have a financial stake in the
payment rates for services paid under the PFS. MedPAC stated that the
Secretary is responsible for establishing RVUs for services, and this
authority should not be delegated to a private entity; therefore, CMS
should independently evaluate the RUC-recommended RVUs based on
objective data and revise them when they are inaccurate. MedPAC also
stated that CMS should collect data from a set of efficient practices
to validate the time estimates and establish more accurate RVUs. Other
commenters stated that from their perspective, CMS is abandoning its
responsibility to set work RVUs under the PFS. One commenter stated
that CMS should actively supervise and take responsibility for setting
physician payments based on reliable, objective evidence. Another
commenter stated that while it appreciates the work of the RUC, they
had concerns that primary care is undervalued by the RUC, and stated
that the RUC tends to favor more procedural and specialty-based
services. The commenter stated that if CMS steps away from taking an
active role in determining RVUs under its own PFS, the agency would be
inflating the role of the RUC and thus underemphasizing primary care in
the process. The commenter also stated that the RUC's final
recommendations do not necessarily strike the balance across different
provider types and services, and that it is the responsibility of CMS,
not the RUC, to set RVUs under the PFS; and therefore, CMS should
retain an active role in evaluating information and data and setting
reimbursement rates for services across the PFS.
Response: We would like to clarify that we are not relinquishing
our obligation to independently establish appropriate RVUs for services
paid under the PFS. We will continue to thoroughly review and consider
information we receive from the RUC, the HCPAC, public commenters,
medical literature, Medicare claims data, comparative databases,
comparison with other codes within the PFS, as well as consultation
with other physicians and healthcare professionals within CMS and the
federal government as part of our process for establishing valuations.
We also note that given the critical role of the resource of time in
establishing work RVUs and the concerns that have been raised about
time values used in rate-setting, we contracted with the Urban
Institute to develop empirical time estimates based on data collected
from several health systems with multispecialty group practices. We
refer readers to the CY 2017 PFS final rule for discussion of the Urban
Institute report (81 FR 80203). While generally proposing the RUC-
recommended work RVUs for new, revised, and potentially misvalued codes
was our approach for CY 2018, we note that we also included alternative
values where we believed there was a possible opportunity for increased
precision.
We also want to clarify that as part of our obligation to establish
RVUs for the PFS, we annually make an independent assessment of the
available recommendations, supporting documentation, and other
available information from the RUC and other commenters to determine
the appropriate valuations. Where we concur that the RUC
recommendations, or recommendations from other commenters, are
reasonable and appropriate and are consistent with the time and
intensity paradigm of physician work, we propose those values as
recommended. Additionally, we will continue to engage with
stakeholders, including the RUC, with regard to our approach for
accurately valuing codes.
CMS appreciates the efforts of the RUC to deliberate on highly
technical matters involving clinical care. The RUC is comprised of 31
physicians, the majority of whom are appointed by major medical
specialty societies. Commenters have noted concerns with the range of
expertise represented in the RUC membership and have advocated for more
balanced representation from across the medical community. Commenters
have also suggested that the RUC should consider how to further engage
the public in its deliberative processes. CMS encourages the RUC to
consider acting on these comments and suggestions in its ongoing
deliberations.
[[Page 53035]]
This action could involve improving the ability of stakeholders or the
public to meaningfully participate in or learn about the deliberations,
considering the balance of primary care and specialty expertise on the
committee, and examining how payers are included in this process.
Stakeholder input could include surveying retired physicians and nurses
in addition to physicians, and receiving additional information about
how payers view relative resource use for services. CMS may also
consider updating its internal review of RUC recommendations in the
future.
Comment: One commenter stated that data obtained through the RUC
survey process, based on subjective physician perceptions of work and
time, may not always be the most accurate data available. The commenter
stated that CMS should be open to reviewing additional sources of
objective and validated work time data furnished by stakeholders. Such
sources might include peer reviewed and published studies of
comparative surgery times among different procedures in the same
institution using standardized metrics.
Response. We continue to be open to reviewing additional and
supplemental sources of data furnished by stakeholders. We encourage
stakeholders to continue to provide such information for CMS
consideration in establishing work RVUs.
Comment: One commenter stated that nurse practitioners have had
little opportunity to participate in RUC activities, and since the fee
schedule recommendations from the RUC impact all clinicians, it is
important that all clinicians, including nurse practitioners, have
input in that process. Another commenter stated that the process for
setting the fee schedule should be accurate and robust, include input
from multiple stakeholders, and be an open process that should have
oversight from, and be transparent to, the many stakeholders who are
affected by the PFS.
Response: We concur that the process of valuing codes should be
accurate and robust, and, as previously stated, we consider input from
various sources when determining the appropriate valuation. Notice and
comment rulemaking provides for an open process whereby we welcome
input from all interested parties, and encourage the commenters to
provide feedback regarding our annual proposed valuations.
We look forward to continuing to engage with stakeholders and
commenters, including the RUC, as we prioritize our obligation to value
new, revised, and potentially misvalued codes, and will continue to
welcome feedback from all interested parties regarding valuation of
services for consideration through our rulemaking process. We refer
readers to section II.H.4 of this final rule for detailed discussion of
the proposed valuation, and alternative valuation considered for
specific codes. Table 12 contains a list of codes for which we proposed
work RVUs; this includes all codes for which we received RUC
recommendations by February 10, 2017. The proposed work RVUs, work time
and other payment information for all proposed CY 2018 payable codes
are available on the CMS Web site under downloads for the CY 2018 PFS
final rule. Table 12 also contains the CPT code descriptors for all
proposed, new, revised, and potentially misvalued codes discussed in
this section.
3. Methodology for the Direct PE Inputs To Develop PE RVUs
a. Background
On an annual basis, the RUC provides us with recommendations
regarding PE inputs for new, revised, and potentially misvalued codes.
We review the RUC-recommended direct PE inputs on a code by code basis.
Like our review of recommended work RVUs, our review of recommended
direct PE inputs generally includes, but is not limited to, a review of
information provided by the RUC, HCPAC, and other public commenters,
medical literature, and comparative databases, as well as a comparison
with other codes within the PFS, and consultation with physicians and
health care professionals within CMS and the federal government, as
well as Medicare claims data. We also assess the methodology and data
used to develop the recommendations submitted to us by the RUC and
other public commenters and the rationale for the recommendations. When
we determine that the RUC's recommendations appropriately estimate the
direct PE inputs (clinical labor, disposable supplies, and medical
equipment) required for the typical service, are consistent with the
principles of relativity, and reflect our payment policies, we use
those direct PE inputs to value a service. If not, we refine the
recommended PE inputs to better reflect our estimate of the PE
resources required for the service. We also confirm whether CPT codes
should have facility and/or nonfacility direct PE inputs and refine the
inputs accordingly.
Our review and refinement of RUC-recommended direct PE inputs
includes many refinements that are common across codes, as well as
refinements that are specific to particular services. Table 13 details
our refinements of the RUC's direct PE recommendations at the code-
specific level. In this final rule, we address several refinements that
are common across codes, and refinements to particular codes are
addressed in the portions of this section that are dedicated to
particular codes. We note that for each refinement, we indicate the
impact on direct costs for that service. We note that, on average, in
any case where the impact on the direct cost for a particular
refinement is $0.30 or less, the refinement has no impact on the PE
RVUs. This calculation considers both the impact on the direct portion
of the PE RVU, as well as the impact on the indirect allocator for the
average service. We also note that nearly half of the refinements
listed in Table 13 result in changes under the $0.30 threshold and are
unlikely to result in a change to the RVUs.
We also note that the direct PE inputs for CY 2018 are displayed in
the CY 2018 direct PE input database, available on the CMS Web site
under the downloads for the CY 2018 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. The inputs
displayed there have also been used in developing the proposed CY 2018
PE RVUs as displayed in Addendum B.
b. Common Refinements
(1) Changes in Work Time
Some direct PE inputs are directly affected by revisions in work
time. Specifically, changes in the intraservice portions of the work
time and changes in the number or level of postoperative visits
associated with the global periods result in corresponding changes to
direct PE inputs. The direct PE input recommendations generally
correspond to the work time values associated with services. We believe
that inadvertent discrepancies between work time values and direct PE
inputs should be refined or adjusted in the establishment of proposed
direct PE inputs to resolve the discrepancies.
(2) Equipment Time
Prior to CY 2010, the RUC did not generally provide CMS with
recommendations regarding equipment time inputs. In CY 2010, in the
interest of ensuring the greatest possible degree of accuracy in
allocating equipment minutes, we requested that the RUC provide
equipment times along with the other direct PE recommendations, and we
provided the RUC with general
[[Page 53036]]
guidelines regarding appropriate equipment time inputs. We continue to
appreciate the RUC's willingness to provide us with these additional
inputs as part of its PE recommendations.
In general, the equipment time inputs correspond to the service
period portion of the clinical labor times. We have clarified this
principle over several years of rulemaking, indicating that we consider
equipment time as the time within the intraservice period when a
clinician is using the piece of equipment plus any additional time that
the piece of equipment is not available for use for another patient due
to its use during the designated procedure. For those services for
which we allocate cleaning time to portable equipment items, because
the portable equipment does not need to be cleaned in the room where
the service is furnished, we do not include that cleaning time for the
remaining equipment items, as those items and the room are both
available for use for other patients during that time. In addition,
when a piece of equipment is typically used during follow-up post-
operative visits included in the global period for a service, the
equipment time would also reflect that use.
We believe that certain highly technical pieces of equipment and
equipment rooms are less likely to be used during all of the preservice
or postservice tasks performed by clinical labor staff on the day of
the procedure (the clinical labor service period) and are typically
available for other patients even when one member of the clinical staff
may be occupied with a preservice or postservice task related to the
procedure. We also note that we believe these same assumptions would
apply to inexpensive equipment items that are used in conjunction with
and located in a room with non-portable highly technical equipment
items since any items in the room in question would be available if the
room is not being occupied by a particular patient. For additional
information, we refer readers to our discussion of these issues in the
CY 2012 PFS final rule with comment period (76 FR 73182) and the CY
2015 PFS final rule with comment period (79 FR 67639).
(3) Standard Tasks and Minutes for Clinical Labor Tasks
In general, the preservice, intraservice, and postservice clinical
labor minutes associated with clinical labor inputs in the direct PE
input database reflect the sum of particular tasks described in the
information that accompanies the RUC-recommended direct PE inputs,
commonly called the ``PE worksheets.'' For most of these described
tasks, there are a standardized number of minutes, depending on the
type of procedure, its typical setting, its global period, and the
other procedures with which it is typically reported. The RUC sometimes
recommends a number of minutes either greater than or less than the
time typically allotted for certain tasks. In those cases, we review
the deviations from the standards and any rationale provided for the
deviations. When we do not accept the RUC-recommended exceptions, we
refine the proposed direct PE inputs to conform to the standard times
for those tasks. In addition, in cases when a service is typically
billed with an E/M service, we remove the preservice clinical labor
tasks to avoid duplicative inputs and to reflect the resource costs of
furnishing the typical service.
We refer readers to section II. B. of this final rule for more
information regarding the collaborative work of CMS and the RUC in
improvements in standardizing clinical labor tasks.
(4) Recommended Items That Are Not Direct PE Inputs
In some cases, the PE worksheets included with the RUC
recommendations include items that are not clinical labor, disposable
supplies, or medical equipment or that cannot be allocated to
individual services or patients. We have addressed these kinds of
recommendations in previous rulemaking (78 FR 74242), and we do not use
items included in these recommendations as direct PE inputs in the
calculation of PE RVUs.
(5) New Supply and Equipment Items
The RUC generally recommends the use of supply and equipment items
that already exist in the direct PE input database for new, revised,
and potentially misvalued codes. Some recommendations, however, include
supply or equipment items that are not currently in the direct PE input
database. In these cases, the RUC has historically recommended that a
new item be created and has facilitated our pricing of that item by
working with the specialty societies to provide us copies of sales
invoices. For CY 2018, we received invoices for several new supply and
equipment items. Tables 13 and 14 detail the invoices received for new
and existing items in the direct PE database. As discussed in section
II.B. of this final rule, we encourage stakeholders to review the
prices associated with these new and existing items to determine
whether these prices appear to be accurate. Where prices appear
inaccurate, we encourage stakeholders to provide invoices or other
information to improve the accuracy of pricing for these items in the
direct PE database during the 60-day public comment period for this
final rule. We expect that invoices received outside of the public
comment period would be submitted by February 10th of the following
year for consideration in future rulemaking, similar to our new process
for consideration of RUC recommendations.
We remind stakeholders that due to the relativity inherent in the
development of RVUs, reductions in existing prices for any items in the
direct PE database increase the pool of direct PE RVUs available to all
other PFS services. Tables 13 and 14 also include the number of
invoices received, as well as the number of nonfacility allowed
services for procedures that use these equipment items. We provide the
nonfacility allowed services so that stakeholders will note the impact
the particular price might have on PE relativity, as well as to
identify items that are used frequently, since we believe that
stakeholders are more likely to have better pricing information for
items used more frequently. A single invoice may not be reflective of
typical costs and we encourage stakeholders to provide additional
invoices so that we might identify and use accurate prices in the
development of PE RVUs.
In some cases, we do not use the price listed on the invoice that
accompanies the recommendation because we identify publicly available
alternative prices or information that suggests a different price is
more accurate. In these cases, we include this in the discussion of
these codes. In other cases, we cannot adequately price a newly
recommended item due to inadequate information. Sometimes, no
supporting information regarding the price of the item has been
included in the recommendation. In other cases, the supporting
information does not demonstrate that the item has been purchased at
the listed price (for example, vendor price quotes instead of paid
invoices). In cases where the information provided on the item allows
us to identify clinically appropriate proxy items, we might use
existing items as proxies for the newly recommended items. In other
cases, we have included the item in the direct PE input database
without any associated price. Although including the item without an
associated price means that the item does not contribute to the
calculation of the proposed PE RVU for particular services, it
facilitates our ability to incorporate a price once we obtain
information and are able to do so.
[[Page 53037]]
(6) Service Period Clinical Labor Time in the Facility Setting
Generally speaking, our proposed inputs did not include clinical
labor minutes assigned to the service period because the cost of
clinical labor during the service period for a procedure in the
facility setting is not considered a resource cost to the practitioner
since Medicare makes separate payment to the facility for these costs.
We address proposed code-specific refinements to clinical labor in the
individual code sections.
(7) Procedures Subject to the Multiple Procedure Payment Reduction
(MPPR) and the OPPS Cap
We note that the public use files for the PFS proposed and final
rules for each year display both the services subject to the MPPR lists
on diagnostic cardiovascular services, diagnostic imaging services,
diagnostic ophthalmology services and therapy services and the list of
procedures that meet the definition of imaging under section
1848(b)(4)(B) of the Act, and therefore, are subject to the OPPS cap
for the upcoming calendar year. The public use files for CY 2018 are
available on the CMS Web site under downloads for the CY 2018 PFS final
rule at For more information regarding the history of the MPPR policy,
we refer readers to the CY 2014 PFS final rule (78 FR 74261-74263). For
more information regarding the history of the OPPS cap, we refer
readers to the CY 2007 PFS final rule (71 FR 69659-69662).
4. Proposed Valuation of Specific Codes for CY 2018
(1) Anesthesia Services for Gastrointestinal (GI) Procedures (CPT Codes
00731, 00732, 00811, 00812, and 00813)
In the CY 2016 PFS proposed rule (80 FR 41686), we discussed that
in reviewing Medicare claims data, a separate anesthesia service is
typically reported more than 50 percent of the time that various
colonoscopy procedures are reported. We discussed that given the
significant change in relative frequency with which anesthesia codes
are reported with colonoscopy services, we believed the relative values
of the anesthesia services should be reexamined and proposed to
identify CPT codes 00740 (Anesthesia for upper gastrointestinal
endoscopic procedures, endoscope introduced proximal to duodenum) and
00810 (Anesthesia for lower intestinal endoscopic procedures, endoscopy
introduced distal to duodenum) as potentially misvalued.
For CY 2018, the CPT Editorial Panel is deleting CPT codes 00740
and 00810 and creating new codes for anesthesia services furnished in
conjunction with and in support of gastrointestinal endoscopic
procedures: Two codes for upper GI procedures, CPT code 00731
(Anesthesia for upper gastrointestinal endoscopic procedures, endoscope
introduced proximal to duodenum; not otherwise specified) and CPT code
00732 (Anesthesia for upper gastrointestinal endoscopic procedures,
endoscopy introduced proximal to duodenum; endoscopic retrograde
cholangiopancreatography (ERCP)); and two codes for lower GI
procedures, CPT code 00811 (Anesthesia for lower intestinal endoscopic
procedures, endoscope introduced distal to duodenum; not otherwise
specified) and CPT code 00812 (Anesthesia for lower intestinal
endoscopic procedures, endoscope introduced distal to duodenum;
screening colonoscopy); and one code for upper and lower GI procedures,
CPT code 00813 (Anesthesia for combined upper and lower
gastrointestinal endoscopic procedures, endoscope introduced both
proximal to and distal to the duodenum).
In the CY 2018 PFS proposed rule, we proposed the RUC-recommended
base units without refinement for CPT codes 00731 (5.00 base units),
00732 (6.00 base units), 00811 (4.00 base units), 00812 (4.00 base
units) and 00813 (5.00 base units). We considered 3.00 base units for
CPT code 00812 based on our comparison of the surveyed post-induction
anesthesia-intensity allocation for CPT code 00812 to codes with
similar allocations, such as CPT code 01382 (Anesthesia for diagnostic
arthroscopic procedures of knee joint). We found that CPT code 01382,
which was also valued with 3 base units, had similar allocations
compared to the survey results for CPT code 00812. We received comments
from anesthesia providers and professional specialty societies,
including the RUC that specifically addressed the codes in this family.
Comment: Regarding CPT code 00812, the RUC stated that its
recommendation of 4.00 base units was made on an interim basis since
the initial survey response rate did not meet the RUC's required
minimum threshold based on the high utilization of predecessor CPT code
00810. Subsequently, the RUC included as part of its public comments a
revised final recommendation of 3.00 base units for CPT code 00812
based on its review of new survey data, with the majority of survey
respondents choosing CPT code 00910 (3.00 base units) as the key
reference code more closely related to the work of CPT code 00812. Some
commenters suggested that CMS should finalize its proposed values for
each code in this family, including the proposed 4.00 base units for
CPT code 00812, and suggested that CPT codes 00812 and 00811 represent
similar work. A few commenters indicated that CPT code 00410 (4.00 base
units) was a better comparator and crosswalk than the alternative
crosswalk to CPT code 01382 that CMS considered for CPT code 00812.
Response: We reviewed additional information submitted by the RUC
as part of its public comment, which included an analysis of new survey
data. We find this additional data persuasive and believe that 3.00
base units better reflects the work of CPT code 00812.
Comment: Several commenters expressed concerns about the process
used for identifying CPT codes 00740 and 00810 as potentially
misvalued. Commenters requested that we maintain the CY 2017 payment
levels for CY 2018, suggesting that if we were to finalize the proposed
base units for each code in this family, it would discourage use of
anesthesia during GI procedures.
Response: We continue to believe that the physician performing the
GI procedure is in the best position to consider the beneficiary's
needs when determining whether to utilize moderate sedation or
anesthesia services. Additionally, while we understand the commenters'
concerns, section 1848(c)(2)(K) of the Act requires the Secretary to
periodically identify potentially misvalued services and to review and
make appropriate adjustments to the relative values for those services.
Section 1848(c)(2)(K) of the Act identifies several categories of
services as potentially misvalued, including codes that have
experienced the fastest growth, along with codes as determined
appropriate by the Secretary. Therefore, as discussed in the CY 2016
PFS proposed rule (80 FR 41686), we indicated that given the
significant change in relative frequency with which anesthesia codes
are reported with colonoscopy services, we believed the relative values
of the anesthesia services should be reexamined as potentially
misvalued.
Comment: Commenters raised concerns about how a change in valuation
for anesthesia services would affect payments made by private insurers.
Response: While we appreciate commenters' concerns, this final rule
[[Page 53038]]
addresses valuation of services for purposes of Medicare payments made
under the PFS. Valuation and payment determinations made by private
insurers are outside the scope of this final rule.
After consideration of comments received that specifically
addressed the codes in this family, for CY 2018, we are finalizing 5.00
base units for CPT codes 00731, 6.00 base units for CPT code 00732,
4.00 base units for CPT code 00811, 3.00 base units for CPT code 00812,
and 5.00 base units for CPT code 00813.
(2) Acne Surgery (CPT Code 10040)
CPT code 10040 (Acne surgery (e.g., marsupialization, opening or
removal of multiple milia, comedones, cysts, pustules) was identified
as potentially misvalued on a screen of Harvard-valued codes with
utilization over 30,000 in CY 2014. In the CY 2018 PFS proposed rule,
we proposed the RUC-recommended work RVU of 0.91 for CPT code 10040 and
the RUC-recommended work time values. We considered using the current
number of 0.5 post-procedure office visits of CPT code 99212 (Office/
outpatient visit est) rather than the RUC-recommended number of 1.0
post-procedure office visits. For CPT code 10040, the RUC stated that
it is a low intensity service that can be performed by a nurse under a
physician's supervision, and that the average number of office visits
in the follow-up period of acne surgery is 0.4. We sought public
comments regarding the typical number of postoperative visits for this
code, considering there have been no changes made to the code
descriptor and we have not found evidence of changes to the typical
patient population.
We proposed the RUC-recommended direct PE inputs for CPT code 10040
without refinement. We considered refinements to the clinical labor for
``Assist physician in performing procedure'' from 10 minutes to 3
minutes. CPT code 10040 previously used about one third of the
intraservice work time for this clinical labor activity (5 minutes out
of 14 minutes), and the RUC-recommended value of 10 minutes would have
increased this to 100 percent of the intraservice work time without
rationale for the change. We considered 3 minutes for this clinical
labor activity, which is about one third of the intraservice work time
(3 minutes out of 10 minutes) and would have maintained the current
ratio between clinical labor time and work time. For CY 2018, we
proposed the RUC-recommended work RVUs and direct PE inputs for CPT
code 10040 and sought comment on our proposed and alternative values.
Comment: Commenters supported the proposed values for CPT code
10040 but disagreed with the alternative values.
Response: We continue to welcome information from all interested
parties regarding valuation of services for consideration through our
rulemaking process. We will continue to consider alternative work RVUs
as we propose the valuation of services for future notice and comment
rulemaking.
After consideration of comments received, for CY 2018, we are
finalizing the work RVUs and direct PE inputs for CPT code 10040 as
proposed.
(3) Muscle Flaps (CPT Codes 15734, 15736, 15738, 15730, and 15733)
CPT codes 15732 and 15736 were identified via a screen of high
level E/M visits included in their global periods. This screen
identified that a CPT code 99214 office visit was included for CPT
codes 15732 and 15736 but not included in the other codes in this
family. During the CPT Editorial Panel's review process for this family
of codes, CPT code 15732 was deleted and replaced with two new codes,
CPT codes 15730 and 15733, to better differentiate and describe the
work of large muscle flaps performed on patients with head and neck
cancer depending on the site where the service was performed.
For CY 2018, we proposed the RUC-recommended work RVUs of 23.00 for
CPT code 15734, 17.04 for CPT code 15736, 19.04 for CPT code 15738,
13.50 for CPT code 15730, and 15.68 for CPT code 15733. For CPT code
15730, we considered a work RVU of 12.03, crosswalking to CPT code
36830 (Creation of arteriovenous fistula by other than direct
arteriovenous anastomosis (separate procedure); nonautogenous graft
(e.g., biological collagen, thermoplastic graft)). We had concerns
because the RUC-recommended work RVU of 13.50 would represent nearly
double the intensity of CPT codes 15734 through 15738, as well as
nearly double the intensity of deleted CPT code 15732. The RUC-
recommended work RVU for CPT code 15730 is also based on a direct
crosswalk to CPT code 36832 (Revision, open, arteriovenous fistula;
without thrombectomy, autogenous or nonautogenous dialysis graft
(separate procedure)), which has the same intraservice time, but with
20 additional minutes of total time. We considered a potential
crosswalk to another code in the same family, CPT code 36830, which
also shares the same intraservice time with CPT code 15730 but differs
by only 8 minutes of total time. However, we sought comment on whether
the RUC recommendation was appropriate given the significant variation
in intensity among these services.
We considered a work RVU of 14.63 for CPT code 15733 (survey 25th
percentile), crosswalking to CPT code 36833 (Revision, open,
arteriovenous fistula; with thrombectomy, autogenous or nonautogenous
dialysis graft (separate procedure)), which has the same intraservice
time, 1 minute of additional total time, and a work RVU of 14.50. We
sought comment on the effect that an alternative work RVU of 14.50
would have on relativity among the codes in this family.
We considered refining the clinical labor time for ``Check
dressings & wound/home care instructions'' for CPT code 15730 from 10
minutes to 5 minutes. We sought comment on the typical time input for
checking dressings, and whether removing and replacing dressings would
typically take place during the intraservice or postservice period.
We also sought comments regarding the use of the new ``plate,
surgical, mini-compression, 4 hole'' (SD189) supply included in CPT
code 15730, including whether use of this supply would be typical, and
if so, whether it should be included in the work description. We noted
that SD189 is mentioned in the direct PE recommendations, but the
supply does not appear in the work description. In the work
description, the fixation screws are applied to the orbital rim and
lateral nasal wall, not the surgical plate.
Comment: Several commenters supported the proposed values for all
five of the codes but disagreed with the alternative values.
Response: We continue to welcome information from all interested
parties regarding valuation of services for consideration through our
rulemaking process. We will continue to consider alternative work RVUs
as we propose the valuation of services for future notice and comment
rulemaking.
Comment: Several commenters stated that the use of the ``plate,
surgical, mini-compression, 4 hole'' (SD189) supply was typical in CPT
code 15730. Commenters mentioned that this supply had a number of
clinical benefits, such as greater stability, less risk of infection,
fewer screws, and a wide area of support. Commenters stated that the
recommendation forms that accompany the work descriptor do not normally
list all supplies or materials used before, during, or after the
surgery in great detail.
[[Page 53039]]
Response: We appreciate the additional information supplied by the
commenters regarding the use of the SD189 supply. While we agree that
the work descriptor for a procedure would not necessarily list all of
the supplies used before, during, or after a surgery, we remain puzzled
at the lack of any mention of the surgical plate in the description of
work for this service. The surgical plate is an expensive ($226) supply
that appears to be integral to the work being performed in this
service. The deleted predecessor code for this service, CPT code 15732,
did not include a surgical plate among its direct PE inputs, and if the
use of the surgical plate is now typical for the new CPT code 15730, we
believe that the description of work for this service would more
accurately explain the work taking place by detailing the use of the
supply. We agree with the commenters regarding the clinical benefits of
the surgical plate, and believe that this should be reflected in the
description of work for this service.
After consideration of comments received, for CY 2018, we are
finalizing the work RVUs and direct PE inputs for the codes in the
muscle flaps family as proposed.
(4) Application of Rigid Leg Cast (CPT Code 29445)
CPT code 29445 (Application of rigid total contact leg cast)
appeared on a high growth screen of all services with total Medicare
utilization of 10,000 or more services that increased by at least 100
percent from 2008 through 2013. This screen also indicated that the
code was last surveyed more than 10 years previously, and that the
dominant specialty had changed during that time.
For CY 2018, we proposed the RUC-recommended work RVU of 1.78 for
CPT code 29445. For the direct PE inputs, we proposed to refine the
clinical labor time for ``Check dressings & wound/home care
instructions'' from 5 minutes to 3 minutes. We believed that the
additional 2 minutes of clinical labor time that we proposed to remove
would take place during the monitoring time following the procedure and
be accounted for in that clinical labor time.
We also considered refining the clinical labor time for ``Remove
cast'' from 22 minutes to 11 minutes: 1 minute for room prep, 10
minutes for assisting the physician, and 0 minutes for the additional
activities described in the RUC recommendations, which would have only
taken place during the initial casting. We had concerns that the RUC-
recommended clinical labor regarding the ``remove cast'' task is based
only on an initial visit where a new cast would be applied and 22
minutes may be an appropriate length of time. However, the RUC
recommendations suggested that four to twelve cast changes are common
for patients, and we sought comment on whether the initial application
of a new cast would be typical for CPT code 29445. We reviewed the
Medicare claims data for CPT code 29445 and found that three or more
castings took place for 52 percent of beneficiaries, which suggests
that three or more castings may be the typical case. A single casting
only took place for 30 percent of services reported with CPT code
29445.
Comment: Several commenters supported the proposed values for CPT
code 29445 but disagreed with the alternative values.
Response: We continue to welcome information from all interested
parties regarding valuation of services for consideration through our
rulemaking process. We will continue to consider alternative work RVUs
as we propose the valuation of services for future notice and comment
rulemaking.
Comment: One commenter stated that they disagreed with our proposal
to refine the clinical labor time for ``Check dressings & wound/home
care instructions'' from 5 minutes to 3 minutes. The commenter did not
supply any rationale for its disagreement.
Response: We continue to believe that the additional 2 minutes of
clinical labor time that we proposed to remove would take place during
the monitoring time following the procedure and be accounted for in
that clinical labor time, since we did not receive any information to
suggest otherwise for CPT code 29445.
After consideration of comments received, for CY 2018, we are
finalizing the work RVUs and direct PE inputs for CPT code 29445 as
proposed.
(5) Strapping Multi-Layer Compression (CPT Codes 29580 and 29581)
The RUC reviewed CPT code 29580 since it appeared on the screen for
high expenditure services and reviewed CPT code 29581 as part of this
family of codes. For CY 2018, the CPT Editorial Panel is deleting two
additional codes in the family: CPT codes 29582 (Application of multi-
layer compression system; thigh and leg, including ankle and foot, when
performed) and 29583 (Application of multi-layer compression system;
upper arm and forearm).
For CY 2018, we proposed the RUC-recommended work RVUs for CPT code
29580 (a work RVU of 0.55) and CPT code 29581 (a work RVU of 0.60).
However, we were concerned about the changes in preservice time
reflected in the specialty surveys compared to the RUC-recommended work
RVUs. For instance, for CPT code 29580, we considered a work RVU of
0.46, crosswalking to CPT code 98925 (Osteopathic manipulative
treatment (OMT); 1-2 body regions involved)), which has a work RVU of
0.46 and shares a similar intraservice time. Compared to the specialty
survey times, the RUC recommended a slight decrease (9 minutes) in
preservice time for CPT code 29580, with the intraservice and immediate
postservice times remaining unchanged.
For CPT code 29581, we considered a work RVU of 0.51 [we note that
in the CY 2018 PFS proposed rule (82 FR 33991), this was cited as 0.50]
by using the RUC-recommended work RVU increment between CPT codes 29580
and 29581 (+0.05), added to the work RVU we considered for CPT code
29580 (0.46), and crosswalking to CPT code 97597 (Debridement (e.g.,
high pressure waterjet with/without suction, sharp selective
debridement with scissors, scalpel and forceps), open wound, (e.g.,
fibrin, devitalized epidermis and/or dermis, exudate, debris, biofilm),
including topical application(s), wound assessment, use of a whirlpool,
when performed and instruction(s) for ongoing care, per session, total
wound(s) surface area; first 20 sq cm or less)), which has similar
intraservice and total times to the RUC-recommended services times for
CPT code 29581. We sought comment on whether a work RVU of 0.51 would
improve relativity among the codes in this family.
For CY 2018, we proposed the RUC-recommended work RVUs for CPT
codes 29580 and 29581 and sought comment on whether the alternative
values we considered would be more appropriate.
Comment: In general, commenters were supportive of our proposal of
the RUC-recommended work RVUs. Some expressed opposition to the
alternative work RVUs.
Response: We will continue to consider alternative work RVUs as we
propose the valuation of services for future notice and comment
rulemaking.
Comment: Several commenters were supportive of the RUC-recommended
PE inputs for these services.
Response: We disagree with the RUC-recommended PE inputs for these
services. We proposed to refine the L037D clinical labor time for
``Provide pre-service education/obtain consent'' from 3 minutes to 2
minutes to conform to the standard for this clinical labor
[[Page 53040]]
activity. The RUC recommendation did not include a written
justification for additional clinical labor time beyond the standard 2
minutes for this activity. As a result, we also proposed to refine the
recommended equipment times for the exam table (EF023) and exam light
(EQ168) to conform to changes in clinical labor time. Thus, we proposed
to refine the equipment times for EF023 and EQ168 to 34 minutes for CPT
code 29580 and to 36 minutes for CPT code 29581, to reflect the service
period time associated with these codes. We continue to believe that
the use of clinical labor standards provides greater consistency among
codes that share the same clinical labor tasks and can improve
relativity of values among codes.
After consideration of comments received, we are finalizing the
work RVUs and direct PE inputs for these services as proposed.
(6) Resection Inferior Turbinate (CPT Code 30140)
CPT code 30140 (Submucous resection inferior turbinate, partial or
complete, any method) was identified as potentially misvalued on a
screen of Harvard-valued codes with utilization over 30,000 in CY 2014.
During the review process, the RUC re-surveyed the code as a 0-day
global period, based on the presence of a negative intensity value in
the initial survey and highly variable postoperative office visits.
For CY 2018, we proposed the RUC-recommended work RVU of 3.00 for
CPT code 30140 as a 0-day global code. We also considered a work RVU of
2.68 for CPT code 30140 and sought comment on changes in practice
patterns since the code was previously reviewed, service times of
comparable services, and whether a work RVU of 2.68 would better
maintain relativity among similar codes. We noted that the RUC-
recommended work RVU of 3.00 nearly doubles the derived intensity of
the code as currently valued. We noted that the RUC recommendations
referenced services that had similar service times to CPT code 30140
(CPT code 31240 (Nasal/sinus endoscopy, surgical; with concha bullosa
resection), with a work RVU of 2.61; and CPT code 31295 (Nasal/sinus
endoscopy, surgical; with dilation of maxillary sinus ostium (e.g.,
balloon dilation), transnasal or via canine fossa), with a work RVU of
2.70.
We noted that the initial survey for CPT code 30140 as a 90-day
global resulted in a RUC-recommended work RVU of 3.57, while the second
survey for the code as a 0-day global resulted in a RUC-recommended
work RVU of 3.00, despite the removal of two postoperative office
visits of CPT code 99212 and a half discharge visit of CPT code 99238.
These removed postoperative visits have a total work RVU of 2.58, which
is notably higher than the difference in the RUC-recommended work RVUs
between the two surveys.
We also proposed to create equipment codes for three new equipment
items based on invoices submitted with the RUC recommendations for CPT
code 30140. We proposed to create three new equipment codes based on
the invoices submitted for this code family: The 2mm reusable shaver
blade (EQ383) at a price of $790, the microdebrider handpiece (EQ384)
at a price of $4,760, and the microdebrider console (EQ385) at a price
of $9,034.
Comment: Several commenters supported the proposed values for CPT
code 30140 but disagreed with the alternative values.
Response: We continue to welcome information from all interested
parties regarding valuation of services for consideration through our
rulemaking process. We will continue to consider alternative work RVUs
as we propose the valuation of services for future notice and comment
rulemaking.
Comment: One commenter requested that CMS add a new supply named
the ``turbinate reduction wand'' to the supply inputs associated with
this procedure when performed in the physician office setting. The
commenter stated that this device is designed to ablate, coagulate, and
remove a core of tissue that provides the desired volumetric reduction
of the anatomy, and supplied several invoices for use in pricing the
new supply.
Response: We note that the suggested turbinate reduction wand has a
price of nearly $200, which would add substantially to the costs of CPT
code 30140. Before including such significant resource costs in the
code, we believe that we should see input from the physician community
such as the RUC. At present, we do not have any information to suggest
that the use of this new supply is typical for CPT code 30140, and the
RUC did not recommend the inclusion of this supply on either of the two
occasions when this code was reviewed in CY 2017. For these reasons, we
do not believe that it would be appropriate to add the turbinate
reduction wand to CPT code 30140 at this time. We welcome the
submission of additional information regarding this use of this supply
from stakeholders.
After consideration of comments received, for CY 2018, we are
finalizing the work RVUs and direct PE inputs for CPT code 30140 as
proposed.
(7) Control Nasal Hemorrhage (CPT Codes 30901, 30903, 30905, and 30906)
In the CY 2018 PFS proposed rule, we proposed the RUC-recommended
work RVU of 1.10 for CPT code 30901, 1.54 for CPT code 30903, 1.97 for
CPT code 30905, and 2.45 for CPT code 30906. We also proposed the RUC-
recommended direct PE inputs for CPT codes 30901, 30903, 30905, and
30906, with standard refinements to the equipment times to account for
patient monitoring times. We noted that as part of its recommendation,
the RUC informed us that the specialty societies presented evidence
stating that the 1995 valuations for these services factored in
excessive times, specifically to account for infection control
procedures that were necessary at that time due to the prevalence of
HIV/AIDS. The specialty societies also noted that increased
availability and use of blood thinner medications compared to those
available in 1995, has increased the difficulty and intensity of these
procedures. We sought additional information regarding the presumption
that the relative resource intensity of these services specifically
would be affected by the commercial availability of additional blood
thinner medications. We stated in the CY 2018 PFS proposed rule that we
believe blood thinner medications were widely available before 1995
when these codes were last valued. We also sought comments on the
prevalence of HIV/AIDS and whether the work related to infection
control procedures would be relative across many PFS services or
specifically related to nasal hemorrhage control procedures.
For CPT code 30901 (Control nasal hemorrhage, anterior, simple
(limited cautery and/or packing) any method), we considered a work RVU
of 1.00 (the 25th percentile survey result), crosswalking to CPT code
20606 (Arthrocentesis, aspiration and/or injection, intermediate joint
or bursa (e.g., temporomandibular, acromioclavicular, wrist, elbow or
ankle, olecranon bursa); with ultrasound guidance, with permanent
recording and reporting), which has similar service times. The median
survey total time (24 minutes) dropped by 2 minutes (from preservice
time), to 24 minutes compared to the existing total time. The
difference in total time reflected a small decrease in preservice time,
with no change in intraservice time (10 minutes). Among codes with
similar service times, we found only three codes that had a higher work
RVU than the RUC-recommended value.
[[Page 53041]]
For CPT code 30903 (Control nasal hemorrhage, anterior, complex
(extensive cautery and/or packing) any method), we considered a work
RVU of 1.30 (the 25th percentile survey result), which would have been
further supported by CPT codes 36584 and 51710, which have similar
service times to the median survey results. The RUC recommended a
decreased total time of 39 minutes compared to the existing total time
(70 minutes), with intraservice time dropping from 30 to 15 minutes.
For CPT code 30905 (Control nasal hemorrhage, posterior, with
posterior nasal packs and/or cautery, any method; initial), we
considered a work RVU of 1.73, using the RUC-recommended work RVU
increment between CPT codes 30903 and 30905 (0.43), added to the work
RVU we considered for CPT code 30903 (1.30), and crosswalking to CPT
code 45321 (Proctosigmoidoscopy, rigid; with decompression of
volvulus), which has similar service times. The surveyed intraservice
time dropped from 48 minutes to 20 minutes. The RUC recommendations
indicated that surveyed service times for CPT code 30905 are longer
than for CPT code 30903 since the service is performed to control an
arterial posterior bleed. According to the specialty society, arterial
posterior bleeds are more difficult to treat and require a more
extensive procedure in comparison to services reported with CPT code
30903. We considered using the RUC-recommended work RVU increment
between CPT codes 30903 and 30905 (0.43), added to the work RVU we
considered for CPT code 30903 (1.30), resulting in a work RVU of 1.73.
We sought comment on whether a work RVU of 1.73 would potentially
affect relativity among the codes in this family.
For CPT code 30906 (Control nasal hemorrhage, posterior, with
posterior nasal packs and/or cautery, any method; subsequent), we
considered a work RVU of 2.21, using the RUC-recommended work RVU
increment between CPT codes 30905 and 30906 (0.48), added to the work
RVU we considered for CPT code 30905 (1.73), and crosswalking to
services with similar service times (CPT codes 19281 (Placement of
breast localization device(s) (e.g., clip, metallic pellet, wire/
needle, radioactive seeds), percutaneous; first lesion, including
mammographic guidance), 51727 (Simple Cystometrogram (CMG) (e.g.,
spinal manometer); with urethral pressure profile studies (i.e.,
urethral closure pressure profile), any technique), 49185
(Sclerotherapy of a fluid collection (e.g., lymphocele, cyst, or
seroma), percutaneous, including contrast injection(s), sclerosant
injection(s), diagnostic study, imaging guidance (e.g., ultrasound,
fluoroscopy) and radiological supervision and interpretation when
performed), and 62305 (Myelography via lumbar injection, including
radiological supervision and interpretation; 2 or more regions (e.g.,
lumbar/thoracic, cervical/thoracic, lumbar/cervical, lumbar thoracic/
cervical)). The surveyed median intraservice time dropped from 60
minutes to 30 minutes. We sought comment on whether a work RVU of 2.21
would potentially improve relativity among the codes in this family.
Given the RUC's consensus, for CY 2018, we proposed the RUC-
recommended work RVUs for each code in this family and sought comment
on whether our alternative values would be more appropriate.
Comment: We received a few comments that specifically addressed our
proposed values for this code family from professional specialty
societies, including the RUC. Commenters expressed support for CMS'
proposed values including the proposed direct PE inputs with standard
refinements to equipment times.
Response: We appreciate the commenters' support and, after
consideration of the comments received that specifically address the
codes in this family, we are finalizing a work RVU of 1.10 for CPT code
30901, a work RVU of 1.54 for CPT code 30903, a work RVU of 1.97 for
CPT code 30905, and a work RVU of 2.45 for CPT code 30906. We are also
finalizing the direct PE inputs as proposed, with standard refinements
to equipment times to account for patient monitoring times.
(8) Nasal Sinus Endoscopy (CPT Codes 31254, 31255, 31256, 31267, 31276,
31287, 31288, 31295, 31296, 31297, 31241, 31241, 31253, 31257, 31259,
and 31298)
In October 2016, the CPT Editorial Panel created five new codes
(CPT codes 31241, 31241, 31253, 31257, 31259 and 31298) and revised CPT
codes 31238, 31254, 31255, 31276, 31287, 31288, 31296, and 31297. CPT
codes 31253--31298 are newly bundled services representing services
that are frequently reported together. CPT code 31241 represents a new
service. The RUC reviewed this family of codes at its January 2017
meeting. For CY 2018, we proposed the RUC-recommended work RVUs for all
15 CPT codes in this family as follows: 4.27 for CPT code 31254, 5.75
for CPT code 31255, 3.11 for CPT code 31256, 4.68 for CPT code 31267,
6.75 for CPT code 31276, 3.50 for CPT code 31287, 4.10 for CPT code
31288, 2.70 for CPT code 31295, 3.10 for CPT code 31296, 2.44 for CPT
code 31297, 8.00 for CPT code 31241, 9.00 for CPT code 31253, 8.00 for
CPT code 31257, 8.48 for CPT code 31259, and 4.50 for CPT code 31298.
For CPT code 31296, we considered a work RVU of 2.82, supported by
a crosswalk to CPT code 36901 (Intro cath dialysis circuit) with an
intraservice time of 25 minutes and total time of 66 minutes, similar
to the service times for CPT code 31296. We were concerned about the
decrease in service time compared to the work RVU and sought comment on
whether or not a work RVU of 2.82 might improve relativity with other
PFS services.
For CPT code 31256, we considered a work RVU of 2.80, supported by
a crosswalk to CPT code 43231 (Esophagoscopy, flexible, transoral; with
endoscopic ultrasound examination), which has 30 minutes of
intraservice time and 81 minutes of total time, similar to the RUC-
recommended service times. We were concerned about the difference in
total time between CPT code 31256 and the RUC-recommended crosswalk to
CPT code 43247. CPT code 43247 has 30 minutes intraservice time and 58
minutes total time), and CPT code 31256 (30 minutes intraservice time
and 83 minutes total time).
For CPT code 31254, we noted the RUC's explanation that this
service is more intense than the functional endoscopic sinus surgery on
the maxillary or sphenoid sinuses due to the risk of major
complications such as injury to the eye muscles, bleeding into the eye
or brain fluid leak and, consequently, that the RUC concluded that it
should be valued higher than either CPT code 31256 or CPT code 31287.
Since CPT code 31256 has the same total time (30 minutes) and
intraservice time (30 minutes) as CPT code 31254, we considered whether
the incremental difference recommended by the RUC between these two
codes (work RVU of 1.16) would reflect the intensity of the service. We
considered a work RVU of 2.80 for CPT code 31256, and also considered
an alternative work RVU of 3.97 for CPT code 31254.
For CPT code 31287, we considered a work RVU of 3.19 based on the
difference between the RUC-recommended work RVU for the maxillary sinus
surgery (CPT code 31256) and the sphenoid sinus surgery (CPT code
31287) (difference = 0.28) added to the work RVU that we considered for
the base code (CPT code 31256, a work RVU of 2.80). We noted that the
magnitude of decreases in
[[Page 53042]]
service times is greater than those for the work RVU, which potentially
could affect relativity among PFS services.
For CPT code 31255, we considered a work RVU of 5.30, based on a
crosswalk to CPT codes 36475 (Endovenous rf 1st vein) and 36478
(Endovenous laser 1st vein) since both of these services have the same
intraservice times, total times, and work RVUs. We noted that there are
several CPT codes with similar total and intraservice times as CPT code
31255 that have lower work RVUs than the RUC's recommended work RVU of
5.75, such as CPT code 36246 (Ins cath abd/l-ext art 2nd), which has 45
minutes intraservice time, 96 minutes total time and a work RVU of 5.02
For CPT code 31276 (Nasal/sinus endoscopy, surgical; with frontal
sinus exploration, including removal of tissue from frontal sinus, when
performed), we considered a work RVU of 6.30, which is similar to other
functional endoscopic surgeries. We noted that the services reported
with CPT code 31276 are the most intense and complex of the functional
endoscopic surgeries due to the risks of working in the narrow confines
in the frontal recess. However, we had concerns regarding the RUC-
recommended crosswalk to CPT code 52352 (Cystourethroscopy, with
ureteroscopy and/or pyeloscopy; with removal or manipulation of
calculus (ureteral catheterization is included)), and sought comment on
whether the RUC-recommended decrease in service times was appropriate
since CPT code 52352 has 20 minutes more total time than CPT code
31276.
For CPT code 31241 (nasal/sinus endoscopy, surgical; with ligation
of Sphenopalatine artery), we had concerns and sought comment regarding
the accuracy and applicability of the surveys as the RUC indicated that
the specialty society did not use the survey instrument that contained
questions about the number and types of visits and that this service
requires including a half day discharge day management as the patients
typically stay overnight to be monitored for further bleeding. We
sought comment on whether inclusion of a half day discharge day visit
was typical for this service since services assigned 0-day global
periods do not typically include discharge visits. We considered
reducing the total time from 142 minutes to 123 minutes by removing the
half day discharge. Using the alternative total time of 123 minutes, we
found services with similar total and intraservice time (60 minutes)
and total time (123 minutes).
We considered a work RVU of 7.30 for CPT code 31241, supported by a
direct crosswalk to CPT code 36253 (Superselective catheter placement
(one or more second order or higher renal artery branches) renal artery
and any accessory renal artery(s) for renal angiography, including
arterial puncture, catheterization, fluoroscopy, contrast injection(s),
image postprocessing, permanent recording of images, and radiological
supervision and interpretation, including pressure gradient
measurements when performed, and flush aortogram when performed;
unilateral), since CPT code 36253 has a similar total time compared to
our alternative total time.
For CPT code 31257, we considered a work RVU of 7.30, based on a
crosswalk to CPT code 36253 (Superselective catheter placement (one or
more second order or higher renal artery branches) renal artery and any
accessory renal artery(s) for renal angiography, including arterial
puncture, catheterization, fluoroscopy, contrast injection(s), image
postprocessing, permanent recording of images, and radiological
supervision and interpretation, including pressure gradient
measurements when performed, and flush aortogram when performed;
unilateral). We had similar concerns regarding the service times for
this service, including the cited reference codes, compared to the RUC-
recommended work RVU. We sought comment on whether a work RVU of 7.30
for CPT code 31257 would improve consistency among the combined CPT
codes in this family.
CPT code 31259 is a new code representing a combination of the
services previously described by CPT codes 31255 and 31288. We noted
the changes in overall service times compared to other codes in this
family and other PFS services. We considered a work RVU of 7.85 for CPT
code 31259, crosswalking to CPT code 93461 (R&l hrt art/ventricle
angio), which has identical intraservice times. We sought comment on
the effect that this alternative work RVU might have on consistency and
rank order compared to the other bundled codes in this family.
CPT code 31298 represents a combination of CPT codes 31296 and
31297. We had concerns about the use of the RUC-recommended comparison
codes, CPT codes 47532 and 58558, due to differences in both
intraservice and total time compared to the service times for CPT code
31298. We considered a work RVU of 4.10 for CPT code 31298,
crosswalking to CPT code 44406 (Colonoscopy w/ultrasound), which has
similar service times.
In the CY 2018 PFS proposed rule, we proposed the RUC-recommended
work RVUs for each code in this family and sought comment on our
alternative values.
Comment: In general, commenters supported the work RVUs for
existing CPT codes in this family as proposed. One commenter expressed
concern about the proposed work RVUs for the newly bundled CPT codes:
CPT code 31253, 31257, 31259, and 31298. The commenter encouraged CMS
to adopt a payment rate for the newly bundled codes that more closely
aligns with the payment if the individual codes are reported separately
on the same claim. Valuing the newly bundled codes as the sum of the
component codes would yield a work RVU of 12.50 for CPT 31253 instead
of the proposed 9.00; a work RVU of 9.25 for CPT 31257 instead of the
proposed 8.00; a work RVU of 9.85 for 31259 instead of the proposed
8.48; and a work RVU of 5.44 for CPT 31298 instead of the proposed
4.50.
Response: We believe that certain efficiencies occur when certain
services are furnished together. From a payment perspective, those
efficiencies are reflected in the multiple procedure payment reduction.
Similarly, when services that used to be described by two separate
codes are combined, those efficiencies are reflected in the work RVU
for the combined code. Therefore, we are finalizing all work RVUs for
the CPT codes in this family, including the newly combined services, as
proposed.
Comment: One commenter noted that a few of the CPT codes have work
RVUs that are decreasing by more than 20 percent and requested that CMS
phase-in these rate reductions.
Response: Section 1848(c)(7) of the Act requires that, if the total
RVUs for a service for a year would otherwise be decreased by an
estimated 20 percent or more as compared to the total RVUs for the
previous year, the applicable adjustments in work, PE, and MP RVUs
shall be phased-in over a 2- year period. We note that the phase-in
requirement does not apply to codes that are new or revised. Therefore,
the CPT codes in this code family with work RVU reductions of greater
than 20 percent are not subject to the phase-in requirement. Please see
section II.F of the CY 2016 PFS final rule with comment period (80 FR
70930) for more information regarding the phase-in of significant RVU
reductions. The document is available on the CMS Web site under
downloads for the CY 2016 PFS final rule with comment period at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
Regarding the recommended direct PE inputs, we expressed concern
about one of the supply items used in furnishing
[[Page 53043]]
services for several CPT codes in this family: ``sinus surgery balloon
(maxillary, frontal, or sphenoid) kit'' (SA106). In the current
recommendations, half of one kit (each kit has sufficient supply for
two sinuses) is included in the PE inputs for CPT codes 31295, 31296,
and 31297. The new CPT code 31298 has one full kit, reflecting a
service consisting of two sinuses, according to the RUC's explanation.
The price of the full kit (two sinuses) of this disposable supply is
$2,599.06. Our analysis of 2016 Medicare claims data indicated that 48
percent of the time one of the three CPT codes (31295, 31296, and
31297) is billed, it is reported on a claim with either one or both of
the other codes. Ten percent of the time one of the three CPT codes is
billed, it is reported on a claim with both of the other two codes.
Effectively, 10 percent of claims reporting these CPT codes are being
paid for three sinuses. We sought comments on the number of units of
this supply item that are used for each service. We welcomed
suggestions about improved methodologies for identifying the quantity
of this disposable supply used during these procedures and will
continue to monitor utilization and reporting of these services.
Comment: We received several comments in response to our request
for input about the number of units of supply item ``sinus surgery
balloon (maxillary, frontal, or sphenoid) kit'' (SA106) that are
appropriate for CPT codes 31295, 31296, 31297, and 31298. Commenters,
including the RUC, noted that each kit includes one balloon, and each
sinus requires 0.5 of a balloon, and that the current PE input of 0.5
of SA106 is appropriate for CPT 31295, 31296, and 31297. Commenters
also noted that, since CPT code 31298 bundles CPT codes 31296 and
31297, an entire balloon kit is appropriate. The RUC also reiterated
support for CMS to develop a standalone HCPCS supply code for the
balloon kit.
Response: We are finalizing the PE input for supply item SA106 as
proposed, which includes 0.5 kit for CPT codes 31295, 31296, and 31297,
and one kit for CPT code 31298.
Comment: One commenter suggested that several PE inputs for CPT
code 31254 are either missing, insufficient, or have an incorrect
price. The commenter also requested that CMS develop nonfacility PE
inputs for CPT code 31255.
Response: After reviewing the commenter's suggestions regarding
supply items for CPT code 31254, we believe that the current supplies
and prices, as developed by the RUC in concert with the specialty
societies, account for the items that are typically involved in
furnishing this service. We refer the commenter to the process by which
additional information for consideration of prices for supply items can
be provided to CMS through the annual rulemaking cycle, in particular
through invoices. Regarding the request to establish nonfacility values
for this code, we have historically proposed payment rates for specific
settings that have been vetted through the RUC process. We also
consider information on Medicare utilization that may indicate trends
on where the service is being furnished to identify when it might be
appropriate to value a code in the nonfacility setting. If stakeholders
are interested in submitting information about PE inputs that reflect
resource costs typical for a particular setting, we encourage
collaboration with the RUC in addressing such inputs. We note that the
valuation of a service under the PFS in particular settings does not
address whether those services are medically reasonable and necessary
in the case of individual patients, including being furnished in a
setting appropriate to the patient's medical needs and condition. We
are finalizing the PE inputs for CPT codes in this family as proposed.
In reviewing the RUC recommendations for this family of CPT codes,
we noted that the CPT codes in this family are subject to the standard
payment adjustment for multiple surgeries. In our analysis of the
claims data, we noted that the average number of HCPCS codes in this
family reported together on a claim line is approximately 2.89. In
addition, about 15 percent of claims have two of the newly bundled CPT
codes reported together on a claim line. We expressed concern about the
frequency with which the nasal sinus endoscopy CPT codes in this family
are billed together. We sought comments on whether we should consider
the endobase code adjustments as a better approach to adjusting payment
for these services instead of the current multiple procedure payment
reduction. For additional information about the payment adjustment
under the special rule for multiple endoscopic services, we refer
readers to the Medicare Claims Processing Manual, Chapter 23 (available
on the CMS Web site at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS018912.html.
Comment: There was no consensus among commenters about whether we
should consider the endobase code adjustments as a better approach to
adjusting payment for these services instead of the multiple procedure
payment reduction. A few commenters stated their opposition, noting
that in cases where multiple endoscopies are provided on the same date
of service, this would result in the base procedure not being
reimbursed, and that this would be grossly inappropriate because these
are therapeutic procedures and each sinus represents very different
work and risks. Other commenters supported the application of the
payment reduction for multiple endoscopic procedures.
Response: We will consider these comments. We welcome feedback from
stakeholders regarding these and other services for which a change in
the indicator status designating the applicable type of multiple
procedure payment reduction might be appropriate. We are finalizing our
proposal to maintain the standard multiple procedure payment reduction
for this group of nasal sinus endoscopy services.
To estimate utilization for new or newly bundled services in this
group of complex codes, we used a different crosswalk to current
services than was recommended by the RUC. We believe that the RUC did
not sufficiently account for utilization changes that occur when
several newly bundled CPT codes describe formerly separate services. We
direct readers to the file called ``CY 2017 Analytic Crosswalk to CY
2018'' on the CMS Web site under downloads for the CY 2018 PFS final
rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
(9) Tracheostomy (CPT Codes 31600, 31601, 31603, 31605, and 31610)
CPT code 31600 was identified as part of a screen of high
expenditure services with Medicare allowed charges of $10 million or
more that had not been recently reviewed. CPT codes 31601, 31603,
31605, and 31610 were added and reviewed as part of the code family.
We proposed the RUC-recommended work RVUs for all five codes in
this family. We proposed work RVUs of 5.56 for CPT code 31600, 8.00 for
CPT code 31601, 6.00 for CPT code 31603, 6.45 for CPT code 31605, and
12.00 for CPT code 31610.
We considered a work RVU of 6.50 for CPT code 31601. We sought
comment on the effect that this alternative value would have on
relativity compared to other PFS services, especially since the survey
data do not suggest an increase in the time required to perform the
procedure.
[[Page 53044]]
We considered a work RVU of 4.77 for CPT code 31605, based on the
survey 25th percentile from the combined survey total. We also
considered an intraservice work time of 15 minutes, based on the median
intraservice work time from the combined survey total for CPT code
31605. We sought comments on the methodology used to determine the RUC-
recommended work RVU and intraservice work time. We were concerned that
the number of respondents (20) was below the threshold typically
required for submission of a survey, and the effect of using survey
results only from physicians who had personal experience performing the
procedure. CPT code 31605 has a lower intraservice and total time, but
a higher work RVU than comparable codes under the PFS. We noted that
the next highest 0-day global code with 20 minutes of intraservice time
is CPT code 16035 (Escharotomy; initial incision) at a work RVU of
3.74. All other 0-day global codes with a work RVU of 6.45 or greater
have at least 40 minutes of intraservice time.
We sought comment on the effect that an alternative work RVU of
4.77 would have on the relativity of this service compared to other
services in this family of codes and compared to other PFS services,
taking into account that CPT code 31605 describes a difficult and
dangerous life-threatening emergency procedure.
We considered a work RVU of 6.50 for CPT code 31610 based on a
direct crosswalk to CPT code 31601 (Incision of windpipe). We
understand that the RUC considered the possibility of recommending this
code be assigned a 0-day global period based on concerns about negative
derived intensity. We shared the RUC's concerns with the current
construction of CPT code 31610, particularly with the 242 minutes of
work time included in the postoperative visits, which is an unusually
large amount for a procedure with only 45 minutes of intraservice time.
We did not identify any other comparable codes under the PFS with 45
minutes of intraservice time and more than 300 minutes of total time.
We sought comment on whether the unusually high volume of physician
work time included in the postoperative visits for CPT code 31610
contributed to the negative derived intensity reported by the survey
data. Considering that the other codes in this family have 0-day global
periods, we considered and sought comment on whether a 0-day global
period should be assigned to CPT code 31610. Removal of the
postoperative E/M visits from CPT code 31610 would result in an
intraservice time of 45 minutes and a total time of 125 minutes,
similar to CPT code 31601 with 45 minutes of intraservice time and 135
minutes of total time.
We proposed the RUC-recommended direct PE inputs for all five CPT
codes in this family without refinements. As discussed earlier, we
considered a 0-day global period for CPT code 31610, which would also
have resulted in removal of the clinical labor associated with the
postoperative E/M visits, along with the supplies and equipment
utilized during those visits. While we remained concerned about the
global period assigned to CPT code 31610 and the changes in service
times reflected in the specialty surveys compared to the RUC-
recommended work RVUs, for CY 2018, we proposed the RUC-recommended
work RVUs and direct PE inputs for each code in this family and sought
comment on our proposed and alternative values.
Comment: The commenters supported the proposed values for all five
of the codes but disagreed with the alternative values.
Response: We appreciate the feedback from the commenters. We
continue to welcome information from all interested parties regarding
valuation of services for consideration through our rulemaking process.
After consideration of comments received, for CY 2018, we are
finalizing the work RVUs, direct PE inputs, and global periods for the
codes in the tracheostomy family as proposed.
(10) Bronchial Aspiration of Tracheobronchial Tree (CPT Codes 31645 and
31646)
CPT code 31645 (Bronchoscopy, rigid or flexible, including
fluoroscopic guidance, when performed with therapeutic aspiration of
tracheobronchial tree, initial) was identified as potentially misvalued
on a screen of Harvard-valued codes with utilization over 30,000 in CY
2014. CPT code 31646 (Bronchoscopy, rigid or flexible, including
fluoroscopic guidance, when performed with therapeutic aspiration of
tracheobronchial tree, subsequent, same hospital stay) was added for
review as part of the family of codes, and both were revised to reflect
recent changes in how the services are typically performed. For CY
2018, we proposed the RUC-recommended work RVUs of 2.88 for CPT code
31645 and 2.78 for CPT code 31646.
We considered a work RVU of 2.72 for CPT code 31645, crosswalking
to CPT code 45347 (Sigmoidoscopy, flexible; with placement of
endoscopic stent). We had concerns regarding the decrease in
intraservice and total time compared to the current values; we also
believe that it is important to note how these related codes have been
affected by the creation of separately billable codes for moderate
sedation (see the CY 2017 PFS final rule (81 FR 80339)). The RUC
recommended a work RVU for CPT code 31645 that is higher than the work
RVU for CPT code 31622 (Bronchoscopy, rigid or flexible, including
fluoroscopic guidance, when performed; diagnostic, with cell washing,
when performed), which is the base procedure for this broader group of
codes. We agreed that CPT code 31645 should be valued at a higher work
RVU than CPT code 31622; however, we sought comment on whether the work
of moderate sedation was inadvertently included in the development of
the recommended work RVU. We noted that as part of the CY 2017 PFS
final rule (81 FR 80339), we finalized separate payment for moderate
sedation. Following the creation of separately billable codes for
moderate sedation, CPT code 31622 is currently valued at a work RVU of
2.53, not 2.78 as it was previously valued, and we did not believe it
would be appropriate to continue to value CPT code 31645 as though
moderate sedation was still an inherent part of the work of this
service. As a result, we considered a direct crosswalk to CPT code
45347, which has the same intraservice time and 8 additional minutes of
total time, at a work RVU of 2.72.
We considered a work RVU of 2.53 for CPT code 31646, crosswalking
to CPT code 31622 (Dx bronchoscope/wash). The RUC recommendation for
CPT code 31646 indicated that the code was comparable to CPT code
31622, since they share the same intraservice time and similar total
time, and that the recommended work RVU of 2.78 for CPT code 31646 was
equal to the work RVU of CPT code 31622 before the CY 2017 changes to
reporting of moderate sedation. We agreed with the survey participants
that these two codes are comparable to one another, but had concerns
about valuation of CPT code 31646 using a cross reference to a code
that included moderate sedation. We considered crosswalking CPT code
31646 using the current CY 2017 valuation for CPT code 31622 (a work
RVU of 2.53).
For the direct PE inputs, we proposed to remove the oxygen gas
(SD084) from CPT code 31645. This supply is included in the separately
billable moderate sedation codes, and we proposed to remove the oxygen
gas as recommended by the RUC's PE Subcommittee as part of the removal
of
[[Page 53045]]
oxygen from non-moderate sedation post-procedure monitoring codes. We
also proposed to remove the equipment time for the IV infusion pump
(EQ032) from CPT code 31645. We did not agree that there would
typically be a need for a separate infusion pump in CPT code 31645, as
the infusion pump is contained in the separately reportable moderate
sedation codes. We also proposed to remove the equipment time for the
CO2 respiratory profile monitor (EQ004) and the mobile instrument table
(EF027) from CPT code 31645. These equipment items are not contained in
the current composition of the code, and there was no rationale
provided in the RUC recommendations for their inclusion. As a result,
we did not believe that their use would be typical for CPT code 31645.
We proposed to increase the equipment time for the flexible
bronchoscopy fiberscope (ES017) for CPT code 31645 consistent with
standard equipment times for scopes. We also proposed to increase the
equipment time for the Gomco suction machine (EQ235) and the power
table (EF031) consistent with standard equipment times for non-highly
technical equipment. For CY 2018, we proposed the RUC-recommended work
RVUs for both codes in this family and sought comment on whether we
should finalize refined values consistent with the implementation of
separately billable codes for moderate sedation.
Comment: Several commenters supported the proposed values for both
of the codes but disagreed with the alternative values.
Response: We continue to welcome information from all interested
parties regarding valuation of services for consideration through our
rulemaking process. We will continue to consider alternative work RVUs
as we propose the valuation of services for future notice and comment
rulemaking.
Comment: One commenter disagreed with our proposal to remove the
oxygen gas (SD084) and the equipment time for the CO2 respiratory
profile monitor (EQ004) from CPT code 31645. The commenter stated that
although the separately reported moderate sedation codes do include
some oxygen, the new codes fail to include enough oxygen for the entire
procedure, and there would be an unacceptable risk to the patient
population if insufficient quantities of oxygen were allotted for this
service. The commenter indicated that the use of these direct PE inputs
was the standard of care for bronchoscopies.
Response: After reviewing the information supplied by the
commenter, we agree that the removal of these two direct PE inputs from
CPT code 31645 could create a risk for the patient population.
Therefore, we are finalizing the inclusion of 175 liters of oxygen gas
and 58 minutes of equipment time for the CO2 respiratory profile
monitor for CPT code 31645.
After consideration of comments received, for CY 2018, we are
finalizing the work RVUs and direct PE inputs for the codes in the
bronchial aspiration of tracheobronchial tree family as proposed, with
the exception of the proposed removal of the oxygen gas and CO2
respiratory profile monitor as detailed above.
(11) Cryoablation of Pulmonary Tumor (CPT Codes 32998 and 32994)
For CY 2018, the CPT Editorial Panel modified the descriptor for
CPT code 32998 (Ablation therapy for reduction or eradication of 1 or
more pulmonary tumor(s) including pleura or chest wall when involved by
tumor extension, percutaneous, including imaging guidance when
performed, unilateral; radiofrequency) to include imaging guidance. In
addition, the panel deleted Category III CPT Code 0304T and replaced it
with a new CPT code 32994, to describe ablation therapy for reduction
of pulmonary tumor using cryoablation with imaging guidance. In the CY
2018 PFS proposed rule, we proposed the RUC-recommended work RVUs for
CPT codes 32998 (a work RVU of 9.03) and 32994 (a work RVU of 9.03).
However, we expressed concerns about the descriptions of the codes
and the recommended valuations assuming that imaging guidance is
inherent to the procedure. Based on our analysis of claims data from
2014, existing CPT code 32998 is currently reported with one of the
three imaging guidance codes (CPT codes 76940, 77013, or 77022) less
than 50 percent of the time. We sought comment on whether there is
additional information that would help explain why the codes are being
bundled despite what is reflected in the Medicare claims data. We
considered a work RVU of 7.69 for CPT code 32998, that included
approximately one half the value of the imaging guidance in the new
codes that describe the work of both the procedure and the image
guidance (that is, the sum of the current work RVU for CPT code 32998
and one-half of the work RVU for CPT code 77013 (the imaging guidance
code most frequently billed with CPT code 32998 according to 2014
claims data)). We applied the same general rationale regarding the use
of imaging guidance for new CPT code 32994. Since the RUC recommended
identical work RVUs for these codes, we also considered a work RVU of
7.69 for CPT code 32994.
For CPT codes 32998 and 32994, we proposed to use the RUC-
recommended direct PE inputs with standard refinements and sought
comment on our proposed values.
Comment: Commenters generally supported the work RVUs for these
codes, as proposed. Some commenters expressed concerns about our
analysis of utilization data related to the bundling of imaging
guidance services with ablation therapy. In addition, commenters
disagreed with our refinement to times for several equipment items.
Response: We continue to remain interested in ensuring that, when
two services are combined into a single CPT code, that they are
furnished together so frequently that the resulting resource valuation
is not inadvertently overestimating resource costs.
After consideration of the public comments, we are finalizing the
work RVUs as proposed. With regard to the PE inputs, we note that we
applied the standard formulas for equipment times, and we continue to
believe that these refinements are reasonable for these codes. An
explanation of the standards and formulas for equipment related to
direct PE inputs is in the CY 2014 PFS final rule with comment period
(79 FR 67557). We are also finalizing the direct PE inputs with
standard refinements for these services, as proposed.
(12) Artificial Heart System Procedures (CPT Codes 33927, 33929, and
33928)
For CY 2018, the CPT Editorial Panel deleted Category III CPT Codes
0051T through 0053T and created CPT codes 33927 (Implantation of a
total replacement heart system (artificial heart) with recipient
cardiectomy), 33929 (Removal of a total replacement heart system
(artificial heart) for heart transplantation), and 33928 (Removal and
replacement of total replacement heart system (artificial heart)) to
report artificial heart system procedures. We proposed the RUC-
recommended work RVU of 49.00 for CPT code 33927, and proposed to
assign contractor-priced status to CPT codes 33929 and 33928, as
recommended by the RUC. We considered assigning contractor-priced
status for CPT code 33927. We had concerns regarding the accuracy of
the RUC-recommended work valuation for CPT code 33927, due to its low
utilization and the resulting difficulties in finding enough
practitioners with direct experience of the procedure for the specialty
societies to survey. We sought comment on the sufficiency of the survey
data, especially since new
[[Page 53046]]
technologies and those with lower utilization are typically contractor-
priced. For CY 2018, we proposed the RUC-recommended work RVUs for CPT
code 33927. We sought comment on this alternative pricing for this CPT
code 33927. We did not propose any direct PE inputs, as we did not
receive RUC-recommended PE information for CPT codes 33927, 33929, and
33928. These three codes will be placed on the RUC's new technology
list and will be re-reviewed by the RUC in 3 years.
Comment: Several commenters supported the proposed values for CPT
code 33927 but disagreed with the alternative values.
Response: We continue to welcome information from all interested
parties regarding valuation of services for consideration through our
rulemaking process. We will continue to consider alternative work RVUs
as we propose the valuation of services for future notice and comment
rulemaking.
After consideration of comments received for CY 2018, we are
finalizing the work RVU of 49.00 for CPT code 33927 and finalizing
contractor-priced status for CPT codes 33929 and 33928 as proposed.
(13) Endovascular Repair Procedures (CPT Codes 34701, 34702, 34703,
34704, 34705, 34706, 34707, 34708, 34709, 34710, 34711, 34712, 34713,
34812, 34714, 34820, 34833, 34834, 34715, and 34716)
The CPT/RUC joint workgroup on codes recommended in October 2015 to
bundle endovascular abdominal aortic aneurysm repair (EVAR) codes
together with radiologic supervision and interpretation codes, since
these codes were typically reported together at least 50 percent of the
time. The CPT Editorial Panel bundled these services together in
September 2016, creating 16 new codes, revising four existing codes,
and deleting 14 other codes related to endovascular repair procedures.
We proposed the RUC-recommended work RVUs for all 20 codes in this
family. We proposed work RVUs of 23.71 for CPT code 34701, 36.00 for
CPT code 34702, 26.52 for CPT code 34703, 45.00 for CPT code 34704,
29.58 for CPT code 34705, 45.00 for CPT code 34706, 22.28 for CPT code
34707, 36.50 for CPT code 34708, 6.50 for CPT code 34709, 15.00 for CPT
code 34710, 6.00 for CPT code 34711, 12.00 for CPT code 34712, 2.50 for
CPT code 34713, 4.13 for CPT code 34812, 5.25 for CPT code 34714, 7.00
for CPT code 34820, 8.16 for CPT code 34833, 2.65 for CPT code 34834,
6.00 for CPT code 34715, and 7.19 for CPT code 34716. We also proposed
the RUC-recommended direct PE inputs without refinement for all 20
codes in the family.
We considered a work RVU of 32.00 for CPT code 34702 based on the
survey 25th percentile, and further supported with a crosswalk to CPT
code 48000 (Placement of drains, peripancreatic, for acute
pancreatitis), which has the same intraservice time of 120 minutes and
a work RVU of 31.95. When we compared the RUC-recommended work RVU to
similar codes valued under the PFS, we were unable to find any 90-day
global services with 120 minutes of intraservice time and approximately
677 minutes of total time that had a work RVU greater than 36.00.
We considered a work RVU of 40.00 for CPT code 34704 based on the
survey 25th percentile, crosswalking to CPT code 33534 (Coronary artery
bypass, using arterial graft(s); 2 coronary arterial grafts) which has
a work RVU of 39.88. CPT code 33534 has 193 minutes of intraservice
time, but a lower total time of 717 minutes. When we compared the RUC-
recommended work RVU for CPT code 34704 to similar codes paid under the
PFS, we were unable to find any 90-day global services with 180 minutes
of intraservice time and approximately 737 minutes of total time that
had a work RVU greater than 45.00.
We considered a work RVU of 40.00 for CPT code 34706 based on the
survey 25th percentile. CPT code 34706 has nearly identical time values
to CPT code 34704, with 2 fewer minutes of intraservice time and total
time, and the RUC-recommended work RVU was the same for both of these
codes. The survey respondents also believed that these two codes had a
comparable amount of work, as the survey 25th percentile work RVU was
40.00 for both codes.
We considered a work RVU of 30.00 for CPT code 34708 based on the
survey 25th percentile and sought comment on whether a work RVU of
30.00 would improve relativity among the codes in this family. CPT code
34708 has identical intraservice and total times as CPT code 34702.
However, we noted that the RUC-recommended work RVU of 36.50 for CPT
code 34708 is higher than the RUC-recommended work RVU of 36.00 for CPT
code 34702. This is the inverse of the relationship between CPT codes
34707 and 34701, which describe the same procedures in a non-emergent
state when a rupture does not take place. CPT code 34707 has a RUC-
recommended work RVU of 22.28, while CPT code 34701 has a RUC-
recommended work RVU of 23.71. We sought comment on whether the RUC-
recommended work RVUs would create a rank order anomaly within the
family by reversing the relationship between these paired codes when
performed in an emergent state. We noted that if CPT codes 34708 and
34702 were valued at the survey 25th percentile, this potential rank
order anomaly disappears; in this scenario, we considered valuing CPT
code 34708 at a work RVU of 30.00 and CPT code 34702 at a work RVU of
32.00. We sought comment on whether these alternative work values would
improve relativity with the RUC-recommended work RVUs for CPT code
34707 (22.28) and CPT code 34701 (23.71), with an increment of
approximately 1.50 to 2.00 RVUs between the two code pairs.
For the eight remaining codes that describe endovascular access
procedures, we considered assignment of a 0-day global period, instead
of the RUC-recommended add-on (ZZZ) global period and subsequently
adding back the preservice and immediate postservice work time, and
increasing the work RVU of each code accordingly using a building block
methodology. We noted that as add-on procedures, these eight codes
would not be subject to the multiple procedure payment discount. We
were concerned that the total payment for these services will be
increasing in the aggregate based on changes in coding that alter MPPR
adjustments, despite the information in the surveys that reflects a
decrease in the intraservice time required to perform the procedures,
and a decrease in their overall intensity as compared to the current
values.
We considered a work RVU of 3.95 for CPT code 34713, based on the
RUC-recommended work RVU of 2.50 plus an additional 1.45 work RVUs.
This additional work results from the addition of 38 total minutes of
preservice work time and 30 minutes of postservice work time based on a
crosswalk to CPT code 37224 (Revascularization, endovascular, open or
percutaneous, femoral, popliteal artery(s), unilateral; with
transluminal angioplasty) as valued by using the building block
methodology. Using the same method, we considered a work RVU of:
6.48 for CPT code 34812 based on maintaining the current
75 minutes of preservice work time and the current 30 minutes of
postservice work time, with a total work RVU of 2.35, added to the RUC-
recommended work RVU of 4.13;
7.53 for CPT code 34714 with the addition of 75 minutes of
preservice work time and 27 minutes of postservice work time to match
CPT code 34833;
9.46 for CPT code 34820 based on maintaining the current
80 minutes of preservice work time and the current 30 minutes of
postservice work time;
[[Page 53047]]
10.44 for CPT code 34833 based on maintaining the current
75 minutes of preservice work time and the current 27 minutes of
postservice work time;
5.00 for CPT code 34834 based on maintaining the current
70 minutes of preservice work time and the current 35 minutes of
postservice work time;
8.35 for CPT code 34715 with the addition of 70 minutes of
preservice work time and 35 minutes of postservice work time to match
CPT code 34834; and
9.47 for CPT code 34716 with the addition of 75 minutes of
preservice work time and 27 minutes of postservice work time to match
CPT code 34833.
We proposed the RUC-recommended work RVUs and direct PE inputs for
each code in this family and sought comment on whether our alternative
values would be more appropriate.
Comment: Several commenters supported the proposed values for all
20 of the codes but disagreed with the alternative values.
Response: We continue to welcome information from all interested
parties regarding valuation of services for consideration through our
rulemaking process. We will continue to consider alternative work RVUs
as we propose the valuation of services for future notice and comment
rulemaking.
After consideration of comments received, for CY 2018, we are
finalizing the work RVUs and direct PE inputs for the codes in the
endovascular repair procedures family as proposed.
(14) Selective Catheter Placement (CPT Codes 36215, 36216, 36217, and
36218)
CPT code 36215 was identified as potentially misvalued on a screen
of Harvard-valued codes with utilization over 30,000 in CY 2014, as
well as on a screen of high expenditure services across specialties
with Medicare allowed charges of over $10 million. CPT codes 36216,
36217, and 36218 were added to the family to be reviewed together with
CPT code 36215.
We proposed the RUC-recommended work RVUs for each code in this
family. We proposed work RVUs of 4.17 for CPT code 36215, 5.27 for CPT
code 36216, 6.29 for CPT code 36217, and 1.01 for CPT code 36218.
We also considered refinements to the intraservice work time for
CPT code 36217 from 60 minutes to 50 minutes, consistent with the RUC's
usual use of the survey median intraservice work time. We had concerns
that the use of the recommended survey 75th percentile intraservice
work time will not be clinically appropriate for this code, as the 75th
percentile time was identical for CPT codes 36216 and 36217, and
therefore, the use of this value would not preserve the incremental,
linear consistency between the work RVU and the intraservice time
within the family.
For the direct PE inputs, we proposed to refine the clinical labor
time for the ``Post-procedure doppler evaluation (extremity)'' activity
from 3 minutes to 1 minute for CPT codes 36215, 36216, and 36217. We
believed that 1 minute would be more typical for this task, as the
practitioner would be able to quickly evaluate if there was an issue
with the extremity because there would be visual signs of arterial
insufficiency resulting from the procedure.
We proposed to remove the equipment time for the mobile instrument
table (EF027) from CPT codes 36215, 36216, and 36217. We believed that
the mobile instrument table would be used for moderate sedation, which
was removed from these procedures in CY 2017 (see the CY 2017 PFS final
rule (81 FR 80339). While we recognized that 180 minutes of post-
procedure monitoring time remains in these codes during which the
stretcher (EF018), IV infusion pump (EQ032), and 3-channel ECG (EQ011)
would remain in use, we did not agree that the mobile instrument table
would typically be in use during this period of monitoring. As a
result, we proposed to remove this equipment time from these three
codes.
While we remained concerned about the use of the survey 75th
percentile intraservice work time for CPT code 36217, for CY 2018, we
proposed the RUC-recommended work RVUs for each code in this family and
sought comment on whether our alternative values would be more
appropriate.
Comment: Commenters supported the proposed values for all four of
the codes but disagreed with the alternative values. We did not receive
any comments specifically requesting the use of the alternative values
for this family of codes.
Response: We appreciate the feedback from the commenters. We
continue to welcome information from all interested parties regarding
valuation of services for consideration through our rulemaking process.
We will continue to consider alternative work RVUs as we propose the
valuation of services for future notice and comment rulemaking.
Comment: Several commenters disagreed with the CMS proposal to
refine the clinical labor time for the ``Post-procedure doppler
evaluation (extremity)'' activity from 3 minutes to 1 minute for CPT
codes 36215, 36216, and 36217. Commenters stated that CMS picked
another time under the impression that clinical staff should be able to
perform this task more quickly and that this was not a reason to change
the recommended clinical labor time.
Response: The response from the commenters did not provide any
rationale as to why a clinical labor time of 3 minutes would be typical
for this activity. We continue to believe that 1 minute would be more
typical for this task, as the practitioner would be able to quickly
evaluate if there was an issue with the extremity via visual signs of
arterial insufficiency.
Comment: Several commenters disagreed with the proposal to remove
equipment time for the mobile instrument table (EF027) from CPT codes
36215, 36216, and 36217. Commenters stated that the office still needed
the instrument table during the postoperative period, outside of
moderate sedation, to house all of the monitoring items.
Response: While we appreciate the concerns raised by the
commenters, we disagree. Storage equipment is a form of indirect PE
that is not individually allocable to services and therefore is not
separately payable. Our methodology incorporates the costs of non-
medical infrastructure, such as cabinets and counter space, as part of
the office rent expenses contained as part of indirect PE. Because the
mobile instrument table is analogous to storage equipment in this
particular circumstance, we continue to believe that it would be
classified as a form of indirect PE and would not typically be in use
during this period of monitoring.
After consideration of comments received, for CY 2018, we are
finalizing the work RVUs and direct PE inputs for the codes in the
selective catheter placement family as proposed.
(15) Treatment of Incompetent Veins (CPT Codes 36470, 36471, 36482,
36483, 36465, and 36466)
In September 2016, the CPT Editorial Panel created four new codes
to describe the treatment of incompetent veins, and revised existing
CPT codes 36470 and 36471. These six codes were reviewed together as
part of the same family of procedures. For CY 2018, we proposed the
RUC-recommended work RVU for all six codes. We proposed work RVUs of
0.75 for CPT code 36470, 1.50 for CPT code 36471, 3.50 for CPT code
36482, 1.75 for CPT code 36483, 2.35 for CPT code 36465, and 3.00 for
CPT code 36466.
We considered a work RVU of 4.38 for CPT code 36482, which would
have been based on the RUC-recommended work RVU of 3.50 plus half of
the RUC-recommended work RVU of CPT code
[[Page 53048]]
36483. We also considered assigning CPT code 36483 a status indicator
of ``bundled.'' The services that would be reported using CPT codes
36482 and 36483 in CY 2018 are currently reported with unlisted CPT
code 37799 (Unlisted procedure, vascular surgery). We had concerns
about how frequently the current services include treatment of an
initial vein (CPT code 36482) as compared to the treatment of initial
and subsequent veins (CPT codes 36482 and 36483 together). We believed
it may be more accurate to describe these services through the use of a
single code, as in the rest of this code family, instead of a base code
and add-on code pair. Under this potential scenario, we looked at the
RUC-recommended crosswalk and noted that the add-on CPT code 36483 was
estimated to be billed 50 percent of the time together with CPT code
36482. We therefore considered adding half of the RUC-recommended work
RVU of CPT code 36483 (0.88) to the RUC-recommended work RVU of CPT
code 36482 (3.50), which would result in a work RVU of 4.38.
We proposed to remove the 2 minutes of clinical labor for the
``Setup scope'' (CA015) activity and add the same 2 minutes of clinical
labor for the ``Prepare room, equipment and supplies'' (CA013) activity
for CPT codes 36482, 36465, and 36466. The RUC-recommended materials
stated that these 2 minutes were a proxy for setting up the ultrasound
machine, and we believe that this 2 minutes was more accurately
described by the ``Prepare room, equipment and supplies'' (CA013)
activity code, since there is no scope equipment utilized in these
procedures. We proposed to maintain the Vascular Tech (L054A) clinical
labor type for these 2 minutes. We also proposed to refine the clinical
labor for the ``Check dressings, catheters, wounds'' (CA029) activity
for CPT codes 36470, 36471, 36482, 36465, and 36466, consistent with
the standard times for this clinical labor activity.
We proposed to remove the six individual 4x4 sterile gauze (SG055)
supplies and replace them with a 4x4 sterile gauze pack of 10 (SG056)
for CPT codes 36470, 36471, 36482, 36465, and 36466. The pack of 10
sterile gauze is cheaper than six individual pieces of sterile gauze,
and we did not agree that it would be typical to pay a higher cost for
fewer supplies. We also proposed to create three new supply codes in
response to the invoices submitted for this family of codes. We
proposed to establish a price of $1,495 for the Venaseal glue (SD323)
supply, a price of $3,195 for the Varithena foam (SD324) supply, and a
price of $40 for the Varithena admin pack (SA125) supply.
We proposed to adjust the equipment times for the surgical light
(EF014), the power table (EF031), and the portable ultrasound unit
(EQ250) for CPT codes 36482, 36465, and 36466, consistent with the
standards for non-highly technical equipment and to reflect the changes
in the clinical labor described in this section of the final rule.
While we remained concerned about the creation of a base code and
add-on code pairing (CPT codes 36482 and 36483) out of services that
are currently reported using an unlisted code, for CY 2018, we proposed
the RUC-recommended work RVUs for each code in this family and sought
comment on whether our alternative values would be more appropriate.
Comment: Several commenters supported the proposed values for all
six of the codes but disagreed with the alternative values.
Response: We appreciate the feedback from the commenters.
Comment: One commenter stated that they agreed with the direct PE
refinements as proposed.
Response: We appreciate the support from the commenter.
After consideration of comments received, for CY 2018, we are
finalizing the work RVUs and direct PE inputs for the codes in the
treatment of incompetent veins family as proposed.
(16) Therapeutic Apheresis (CPT Codes 36511, 36512, 36513, 36514,
36516, and 36522)
CPT code 36516 was nominated as potentially misvalued in the CY
2016 PFS proposed rule. The CPT Editorial Panel deleted CPT code 36515
and made revisions to CPT code 36516 to include immunoabsorption. CPT
codes 36511, 36512, 36513, 36514, and 36522 were added to CPT code
36516 to be reviewed together as part of the therapeutic apheresis
family.
For CY 2018, we proposed the RUC-recommended work RVUs for all six
codes in the family. We proposed work RVUs of 2.00 for CPT code 36511,
2.00 for CPT 36512, 2.00 for CPT code 36513, 1.81 for CPT code 36514,
1.56 for CPT code 36516, and 1.75 for CPT code 36522.
We proposed to use the RUC-recommended direct PE inputs for these
codes without refinement. We considered refining the clinical labor
time for the ``Prepare room, equipment, supplies'' activity from 20
minutes to 10 minutes for CPT codes 36514 and 36522, and from 30
minutes to 10 minutes for CPT code 36516. We also considered refining
the clinical labor for the ``Prepare and position patient/monitor
patient/set up IV'' activity from 15 minutes to 10 minutes for these
same three codes. In both cases, we considered maintaining the current
clinical labor time for CPT codes 36514 and 36516, and adjusting the
clinical labor time for CPT code 36522 to match the other two codes in
the family. We had concerns about the lack of a rationale provided for
these changes in clinical labor time, and whether these clinical labor
tasks would typically require this additional time.
We proposed the RUC-recommended work RVUs and to use the RUC-
recommended direct PE inputs for each code in this family and sought
comment on whether our alternative values would be more appropriate. We
also sought comment on whether these procedures were creating a new
point of venous access or utilizing a previously placed access.
Comment: Several commenters supported the proposed values for all
six of the codes but disagreed with the alternative values.
Response: We continue to welcome information from all interested
parties regarding valuation of services for consideration through our
rulemaking process. We will continue to consider alternative work RVUs
as we propose the valuation of services for future notice and comment
rulemaking.
Comment: Several commenters stated that a cell separator system
(EQ084) was mistakenly left out of the RUC's recommendation for CPT
code 36516. The commenters stated that this particular equipment item
is critical for all of the therapeutic apheresis services and that CPT
code 36516 uses a piece of equipment (the Liposorber system) that
attaches to this missing equipment item. The commenters recommended
adding this piece of equipment (EQ084) to CPT code 36516 with 324
minutes of use.
Response: We disagree with the commenters. Based on the information
that we currently have available, we do not believe that the cell
separator system (EQ084) was mistakenly left out of the RUC
recommendation for CPT code 36516. We note that the RUC did not include
the cell separator system in its recommendations for this procedure,
and also made no mention of an error in the recommended direct PE
inputs for CPT code 36516 in its comments on the CY 2018 PFS proposed
rule. We are also confused by the statement from one commenter that the
cell separator system is critical for all of the therapeutic apheresis
services, since this equipment item is not included in the current
direct PE inputs for CPT
[[Page 53049]]
code 36516, nor was it recommended for CPT code 36522 in the same
family. We welcome additional feedback from stakeholders regarding
whether the use of the cell separator system is typical in CPT code
36516.
Comment: Many commenters responded to the request for additional
information regarding whether these procedures were creating a new
point of venous access or utilizing a previously placed access point.
Commenters agreed that both of the vignettes for these services, as
well as the descriptions of work, stated that the typical patient has a
previously placed venous access that is then utilized. While in some
cases, a revision to the access site may need to be made, or initial
access achieved, these cases were not representative of the typical
patient scenario. There was widespread agreement from the commenters on
the utilization of a previously placed access point in these services.
Response: We appreciate the feedback from the commenters in
clarifying the clinical details surrounding the point of venous access.
After consideration of comments received, for CY 2018, we are
finalizing the work RVUs and direct PE inputs for the codes in the
therapeutic apheresis family as proposed.
(17) Insertion of Catheter (CPT Codes 36555, 36556, 36620, and 93503)
CPT code 36556 was identified as part of a screen of high
expenditure services with Medicare allowed charges of $10 million or
more that had not been recently reviewed. CPT codes 36555, 36620, and
93503 were added for review by the RUC as part of the code family. We
proposed the RUC-recommended work RVUs for each code in this family. We
proposed work RVUs of 1.93 for CPT code 36555, 1.75 for CPT code 36556,
1.00 for CPT code 36620, and 2.00 for CPT code 93503.
We proposed to remove the clinical labor time for the ``Monitor pt.
following procedure'' activity and the equipment time for the 3-channel
ECG (EQ011) for CPT code 36555. CPT code 36555 no longer includes
moderate sedation as part of the procedure (see the CY 2017 PFS final
rule (81 FR 80339). We proposed to remove the direct PE inputs related
to moderate sedation from CPT code 36555 as they would now be included
in the separately reported moderate sedation services. We also proposed
to refine the equipment times for the exam table (EF023) and the exam
light (EQ168) to reflect changes in the clinical labor time.
Comment: Several commenters requested that CMS not finalize its
proposal to accept the RUC's recommendations for CPT codes 36555,
36556, 36620 and 93503 and instead finalize higher work RVUs that the
specialty had provided to the RUC. The commenters stated that these
work RVUs maintained relativity within the resource-based relative
value scale (RBRVS) range of services and represented a more accurate
valuation of these procedures. One commenter stated that the RUC-
recommended work RVUs create a rank order anomaly in the intensity of
the services in this family of codes.
Response: As we stated in the background of this code valuation
section, we generally proposed RUC-recommended work RVUs for new,
revised, and potentially misvalued codes for CY 2018. We believe that
in the absence of other data regarding the appropriate valuation of
these codes, the RUC-recommended work RVUs represent the most accurate
valuation of the procedures. We continue to be open to reviewing
additional and supplemental sources of data furnished by stakeholders.
We encourage stakeholders to continue to provide such information for
consideration in establishing work RVUs.
Comment: Several commenters disagreed with the proposal to remove
the direct PE inputs related to moderate sedation from CPT code 36555.
The commenters stated that any PE refinement necessary to address
separate reporting of moderate sedation would have already taken place,
so no further refinement to PE as it relates to this change should be
necessary. Another commenter indicated agreement with the proposed
direct PE refinements.
Response: We appreciate the support from the commenter for our
proposed direct PE refinements. Regarding the other comments, we
continue to believe that further refinements are needed to address the
separate reporting of moderate sedation. CPT code 36555 does not
currently contain any clinical labor for post procedure clinical labor
monitoring related to moderate sedation; however, 7.5 minutes of
monitoring time was added back into the procedure as part of the RUC-
recommended direct PE inputs for CY 2018. Since this clinical labor for
the monitoring time would be included in the separately reported
moderate sedation code, we believe that it would be duplicative to
include the same monitoring clinical labor time, or the equipment time
for the 3-channel ECG, in CPT code 36555.
After consideration of comments received, for CY 2018, we are
finalizing the work RVUs and direct PE inputs for the codes in the
insertion of catheter family as proposed.
(18) Insertion of PICC Catheter (CPT Code 36569)
CPT code 36569 was identified as part of a screen of high
expenditure services with Medicare allowed charges of $10 million or
more that had not been recently reviewed. For CY 2018, we proposed the
RUC-recommended work RVU of 1.70 for CPT code 36569.
We proposed to remove the equipment time for the exam table
(EF023), as this equipment item is a component part of the
radiographic-fluoroscopic room (EL014) included in CPT code 77001
(Fluoroscopic guidance for central venous access device placement,
replacement (catheter only or complete), or removal). Because CPT code
36569 is typically billed together with CPT code 77001, we believed
that including the additional equipment time for the exam table in CPT
code 36569 would be duplicative.
Comment: Several commenters disagreed with the proposal to remove
the equipment time for the exam table (EF023). Commenters stated that
CMS' rationale for removing the exam table, that it is a component part
of the radiographic-fluoroscopic room (EL014), was incorrect.
Commenters pointed out that the radiographic-fluoroscopic room only
includes a radiographic machine and camera, and requested that the exam
table should be reinstated consistent with the RUC's recommendation.
Response: We appreciate the clarification regarding the contents of
the radiographic-fluoroscopic room from the commenters. After reviewing
the room's contents, we agree with the commenters that the
radiographic-fluoroscopic room only includes a radiographic machine and
camera. While we believe that the radiographic machine likely
incorporates an exam table on which to place the patient, we concede
that this is not specifically stated in the documentation for the
radiographic-fluoroscopic room from the commenters. As a result, we are
not finalizing our proposal to remove the equipment time for the exam
table. We are restoring the exam table to CPT code 36569 at an
equipment time of 32 minutes in accordance with our standard formula
for non-highly technical equipment time.
After consideration of comments received, for CY 2018, we are
finalizing the work RVUs and direct PE inputs for the codes for CPT
code 36569 as proposed, with the exception of the
[[Page 53050]]
change for the exam table as detailed above.
(19) Bone Marrow Aspiration (CPT Codes 38220, 38221, 38222, and 20939)
CPT code 38221 was identified as part of a screen of high
expenditure services with Medicare allowed charges of $10 million or
more that had not been recently reviewed. The descriptors for CPT codes
38220 and 38221 were revised to reflect changes in practice patterns,
and two new CPT codes (38222 and 20939) were created to more accurately
describe new services that are now available. For CY 2018, we proposed
the RUC-recommended work RVUs for each code in this family. We proposed
a work RVU of 1.20 for CPT code 38220, 1.28 for CPT code 38221, 1.44
for CPT code 38222, and 1.16 for CPT code 20939.
We also received a recommendation from the RUC to change the global
periods for CPT codes 38220, 38221, and 38222 from XXX global periods
to 0-day global periods, even though these codes were surveyed under
the XXX global period. We agreed with the recommendation that for these
three particular codes, their services were more accurately described
when assigned 0-day global periods as opposed to the XXX global status.
Therefore, we proposed to assign a 0-day global period to all three
codes in this family. We noted, however, that we believed that global
period changes must be addressed on an individual basis, especially
when the routine survey methodologies rely on assumptions regarding
global periods for particular codes. Subsequently, we proposed to
refine the preservice work time from 15 minutes of evaluation time to 9
minutes of evaluation time, 1 minute of positioning time, and 5 minutes
of scrub, dress, and wait time. We proposed these refinements to the
work times for these three codes to more closely align with the
preservice times of other recently reviewed 0-day global procedures,
such as CPT code 30903 (Control nasal hemorrhage, anterior, complex
(extensive cautery and/or packing) any method). We also noted that
given our proposal to value CPT code 38222, we proposed to eliminate
payment using HCPCS code G0364 for CY 2018 since the changes to the set
of CPT codes will now accurately describe the services currently
reported by HCPCS code G0364. For CPT code 20939, we considered a work
RVU of 1.00 based on a direct crosswalk to CPT codes 64494
(Injection(s), diagnostic or therapeutic agent, paravertebral facet
(zygapophyseal) joint (or nerves innervating that joint) with image
guidance (fluoroscopy or CT), lumbar or sacral; second level) and 64495
(Injection(s), diagnostic or therapeutic agent, paravertebral facet
(zygapophyseal) joint (or nerves innervating that joint) with image
guidance (fluoroscopy or CT), lumbar or sacral; third and any
additional level(s)). CPT code 20939 is a global ZZZ add-on code for
CPT code 38220, and we were concerned with maintaining relativity among
PFS services, considering that an add-on code typically has
significantly less intraservice time and total time compared to the
base code. We considered an alternative crosswalk to CPT codes 64494
and 64495, which share the same intraservice and total time with CPT
code 20939 and have work RVUs of 1.00.
We also proposed to refine the clinical labor for ``Lab Tech
activities'' from 12 minutes to 9 minutes for CPT code 38220, from 7.5
minutes to 7 minutes for CPT code 38221, and from 12.5 minutes to 10
minutes for CPT code 38222. We maintained the current time value for
the two existing codes, as we had no reason to believe that the typical
duration has increased for these lab activities. We assigned 10 minutes
for CPT code 38222 based on the statement in the RUC-recommended
materials for the direct PE inputs that this activity takes 0.5 minutes
longer than it does in the current version of CPT code 38220. We also
proposed to remove the breakout lines for the lab activities. We
believe that the breakout of activities into numerous subactivities
generally tends to inflate the total time assigned to clinical labor
activities and results in values that are not consistent with the
analogous times for other PFS services.
We considered refining the clinical labor time for ``Provide
preservice education/obtain consent'' for CPT codes 38220, 38221, and
38222 from 12 minutes to 6 minutes. We had concerns regarding whether
12 minutes would be typical for education and consent prior to these
procedures, as much of the patient education takes place following the
procedure, in the clinical labor activity described under the ``Check
dressings & wound/home care instructions'' heading. We proposed the
RUC-recommended work RVUs for each code in this family and sought
comment on whether our alternative values would be more appropriate.
Comment: Several commenters agreed with the proposal to change the
global period for CPT codes 38220, 38221, and 38222 from XXX global
periods to 0-day global periods. These commenters also supported the
proposed change to the preservice work times to more closely align with
the preservice times of other recently reviewed 0-day global
procedures.
Response: We appreciate the support for our proposal from the
commenters.
Comment: Other commenters disagreed with the proposed change in
global period. Commenters stated that maintaining these codes as XXX
globals was consistent with the survey methodology used to generate the
RUC-recommended work RVUs, as these codes were surveyed under the XXX
global period. The commenters stated that these codes are billed less
than 25 percent of the time with an E/M service, and that since an E/M
service being performed on the same day is not typical, there was not a
compelling reason to change the global period.
Response: We appreciate the additional responses from commenters
requesting that the XXX global period should be retained for these
three CPT codes. As these codes were surveyed and valued under XXX
global status and the RUC has maintained that there is a need to
resurvey when the global period changes, we will not finalize our
proposal to change CPT codes 38220, 38221, and 38222 from XXX global
periods to 0-day global periods. In the absence of compelling evidence
that the 0-day global status would be more typical for these services,
we believe that the current XXX global period should be maintained. We
will also not finalize our related proposal to refine the preservice
work time from 15 minutes of evaluation time to 9 minutes of evaluation
time, 1 minute of positioning time, and 5 minutes of scrub, dress, and
wait time. We welcome additional feedback from stakeholders regarding
the global period that should be assigned to these codes.
Comment: Several commenters supported the proposed values for all
four of the codes but disagreed with the alternative values.
Response: We continue to welcome information from all interested
parties regarding valuation of services for consideration through our
rulemaking process. We will continue to consider alternative work RVUs
as we propose the valuation of services for future notice and comment
rulemaking.
Comment: Several commenters disagreed with the proposal to refine
the clinical labor for ``Lab Tech activities'' in CPT codes 38220,
38221, and 38222. Commenters stated that each CPT code is unique and
the recommended clinical labor reflects the typical time of those
activities associated with each service. Commenters also disagreed with
the proposal to remove the breakout lines for the lab activities,
stating that the
[[Page 53051]]
methodology at the time of review was to provide as much detail as
possible and that just because these subactivities were fully displayed
did not mean that they had been double counted. Several of the
commenters supplied clinical information describing the activities that
took place in additional detail.
Response: We appreciate the additional information supplied by the
commenters. We agree with the commenters that each service is unique
and must be valued on an individual basis. We also agree that the lab
activities taking place in these services are important and that they
must be performed. Our concern is that the individual accounting of
clinical labor activities can lead to PE proliferation, and that this
breakout of activities into numerous subactivities generally tends to
inflate the total time assigned to clinical labor activities and
results in values that are not consistent with the analogous times for
other PFS services. In the case of these codes, we believe that
maintaining the current clinical labor times as proposed will better
serve the purposes of ensuring relativity. We will continue to look for
additional information related to the clinical labor assigned to lab
activities, and we welcome additional feedback from stakeholders.
After consideration of comments received, for CY 2018, we are
finalizing the work RVUs and direct PE inputs for the codes in the bone
marrow aspiration family as proposed. We are not finalizing the
proposal to change CPT codes 38220, 38221, and 38222 from XXX global
periods to 0-day global periods, and we are not finalizing the related
proposal to refine the preservice work time from 15 minutes of
evaluation time to 9 minutes of evaluation time, 1 minute of
positioning time, and 5 minutes of scrub, dress, and wait time for
these three codes.
(20) Esophagectomy (CPT Codes 43107, 43112, 43117, 43286, 43287, and
43288)
CPT codes 43286, 43287, and 43288 were created by the CPT Editorial
Panel to report esophagectomy via laparoscopic and thoracoscopic
approaches. CPT codes 43107, 43112, and 43117 were also reviewed as
part of the family with the three new codes. CPT code 43112 was revised
to clarify the nature of the service being performed. We proposed the
RUC-recommended work RVUs for all six codes in the family. We proposed
work RVUs of 52.05 for CPT code 43107, 62.00 for CPT code 43112, 57.50
for CPT code 43117, 55.00 for CPT code 43286, 63.00 for CPT code 43287,
and 66.42 for CPT code 43288.
We also proposed the RUC-recommended work times for all six codes
in this family. We considered removing 20 minutes from the preservice
evaluation work time from all six of the codes in this family. We had
concerns as to whether this additional evaluation time should be
included for surgical procedures, due to the lack of evidence
indicating that it takes longer to review outside imaging and lab
reports for surgical services than for non-surgical services. We also
considered refining the preservice positioning work time and the
immediate postservice work time for all six of the codes in this family
consistent with standard preservice and postservice work times
allocated to other PFS services.
We had concerns about the presence of two separate surveys
conducted for the three new CPT codes. We noted that CPT codes 43286,
43287, and 43288 were surveyed initially in January 2016, and then were
surveyed again in October 2016 together with CPT codes 43107, 43112,
and 43117 due to concerns about the description of the typical patient
in the original vignette and a change in the codes on the reference
service list (RSL). We noted that CPT codes 43286 and 43287 had the
same median intraservice time on both surveys, while CPT code 43288 had
a median intraservice time that was an hour longer on its second survey
(420 minutes) as compared to its first survey (360 minutes). We also
noted that the total survey time for CPT code 43286 decreased from
1,058 minutes in the first survey to 972 minutes in the second survey,
while the median work RVU increased from 50.00 to 65.00. We did not
understand how the survey median intraservice time could increase so
significantly from the first survey to the second survey for CPT code
43288, or how the surveyed times for CPT code 43286 could be decreasing
while the work RVU was simultaneously increasing by 15.00 work RVUs.
Based on our analysis, it appeared that the accompanying RSL was
the main difference between the two surveys; the codes on the initial
RSL had a median work RVU of 44.18, while the codes on the second RSL
had a median work RVU of 59.64. This increase of 15.00 work RVUs
between the two RSLs that accompanied the surveys appeared to account
for the increase in the work RVUs for the three new codes. We were
concerned that the second survey may have overestimated the work
required to perform these procedures, as the 25th percentile work RVU
of the second survey was higher than the median work RVU of the initial
survey for all three codes, despite no change in the median
intraservice work time for CPT codes 43286 and 43287.
Given these concerns, we considered a work RVU of 50.00 for CPT
code 43286, a work RVU of 60.00 for CPT code 43287, and a work RVU of
61.00 for CPT code 43288, by using the survey median work RVU from the
first survey for the three new codes. For CPT codes 43107 and 43117, we
considered employing the intraservice time ratio between the
laparoscopic version of the procedure represented by the new code and
the open version of the same procedure represented by the existing
code.
We considered a work RVU of 45.00 for CPT code 43107 based on the
intraservice time ratio with CPT code 43286 and a work RVU of 55.00 for
CPT code 43117 based on the intraservice time ratio with CPT code
43287. CPT code 43107 has 270 minutes of intraservice time as compared
with 300 minutes of intraservice time for CPT code 43286, which
produces a ratio of 0.9, and when multiplied by a work RVU of 50.00
(CPT code 43286), results in the proposed work RVU of 45.00. We
considered using the same methodology for CPT codes 43117 and 43287.
Finally, we considered a work RVU of 58.94 for CPT code 43112 based
on a direct crosswalk to CPT code 46744 (Repair of cloacal anomaly by
anorectovaginoplasty and urethroplasty, sacroperineal approach). We
noted that the intraservice time ratio when applied to CPT codes 43112
and 43288, the paired McKeown esophagectomy procedures, would have
produced a potential work RVU of 52.29, creating a rank order anomaly
within the family by establishing a higher work RVU for CPT code 43117
than CPT code 43112, and we were concerned with whether this was an
appropriate valuation for the code.
We sought comment on whether the alternative work RVUs that we
considered might reflect the relative difference in work more
accurately between the six codes in the family. We noted, for example,
that these valuations corrected the rank order anomaly between CPT
codes 43112 and 43121 as noted in the RUC recommendations.
We proposed the RUC-recommended direct PE inputs for all six codes
in the family without refinement. We considered changing the preservice
clinical labor type for all six codes from an RN (L051) to an RN/LPN/
MTA blend (L037D). We had concerns about whether the use of RN clinical
labor would be typical for filling out referral forms or for scheduling
space and equipment in the facility. We also
[[Page 53052]]
considered removing the additional clinical labor time for the
``Additional coordination between multiple specialties for complex
procedures (e.g., tests, meds, scheduling)'' activity, consistent with
preservice standards for codes with 90-day global periods. We were
concerned that this time would not typically be included in non-
surgical procedures performed by other specialties even when additional
coordination is required. We sought comment regarding the changes in
the valuation between the two surveys, the preservice and immediate
postservice work times, and the RN staffing type employed for routine
preservice clinical labor.
Comment: Several commenters supported the proposed values for all
six of the codes but disagreed with the alternative values.
Response: We continue to welcome information from all interested
parties regarding valuation of services for consideration through our
rulemaking process. We will continue to consider alternative work RVUs
as we propose the valuation of services for future notice and comment
rulemaking.
After consideration of comments received, for CY 2018, we are
finalizing the work RVUs and direct PE inputs for the codes in the
esophagectomy family as proposed.
(21) Transurethral Electrosurgical Resection of Prostate (CPT Code
52601)
CPT code 52601 appeared on a screen of potentially misvalued codes,
which indicated that it was performed less than 50 percent of the time
in the inpatient setting, yet included inpatient hospital E/M services
within the global period. For CY 2018, we proposed the RUC-recommended
work RVU of 13.16 for CPT code 52601 and proposed to use the RUC-
recommended direct PE inputs without refinements.
We considered a work RVU of 12.29 for CPT code 52601 based on a
direct crosswalk to CPT code 58541 (Laparoscopy, surgical,
supracervical hysterectomy, for uterus 250 g or less), which is one of
the reference codes. CPT code 58541 may potentially be a more accurate
crosswalk for CPT code 52601 than the RUC-recommended direct crosswalk
to CPT code 29828 (Arthroscopy, shoulder, surgical; biceps tenodesis).
Although all three of these codes share the same intraservice time of
75 minutes, CPT code 58541 is a closer match in terms of the total time
at only 10 minutes difference. CPT code 58541 also shares the same
postoperative office visits as CPT code 52601, a pair of CPT code 99213
office visits, while CPT code 29828 also contains two CPT code 99212
office visits that are not present in the reviewed code.
We noted that if we were to use a reverse building block
methodology for CPT code 52601 and subtract out the value of the E/M
visits being removed, the proposed work RVU would be 11.21. We did not
propose this work RVU; however, because as we noted in the CY 2017 PFS
final rule (81 FR 80274), we agree that the per-minute intensity of
work is not necessarily static over time or even necessarily during the
course of a procedure. Instead, we utilize time ratios and building
block methodologies to identify potential values that account for
changes in time and compare these values to other PFS services for
estimates of overall work. When the values we develop reflect a similar
derived intensity, we agree that our values are the result of our
assessment that the relative intensity of a given service has remained
similar. For CPT code 52601, we were concerned about how the RUC-
recommended derived intensity of the procedure could be increasing by
30 percent over the current derived intensity, while at the same time
the typical site of service was changing from inpatient to outpatient
status. In other words, if it was now typical for CPT code 52601 to be
performed on an outpatient basis, then we would generally expect the
intensity of the procedure to be decreasing, not increasing. We
considered a work RVU of 12.29 for CPT code 52601 based on a direct
crosswalk to CPT code 58541 (Lsh uterus 250 g or less), and sought
comment on whether this alternative value might better reflect
relativity.
Comment: Several commenters supported the proposed values for CPT
code 52601 but disagreed with the alternative values.
Response: We appreciate the feedback from the commenters. We
continue to welcome information from all interested parties regarding
valuation of services for consideration through our rulemaking process.
After consideration of comments received, for CY 2018, we are
finalizing the work RVUs and direct PE inputs for CPT code 52601 as
proposed.
(22) Peri-Prostatic Implantation of Biodegradable Material (CPT Code
55874)
In October 2016, the CPT Editorial Panel deleted CPT Category III
code 0438T and created a new CPT code 55874 (Transperineal placement of
biodegradable material, peri-prostatic, single or multiple
injection(s), including image guidance, when performed). For CY 2018,
we proposed the RUC-recommended work RVU of 3.03 for CPT code 55874.
In reviewing the RUC recommendations, we noted a decrease in
preservice time (30 minutes) compared to the current value. In order to
account for this change in time, we considered calculating the
intraservice time ratio between the key reference code (CPT code
49411), which has an intraservice time of 40 minutes, and the RUC-
recommended intraservice time (30 minutes) and multiplying that by the
work RVU for CPT code 49411 (3.57), which would have resulted in a work
RVU of 2.68. A work RVU of 2.68 would have been further supported by a
bracket of two crosswalk codes, CPT code 65779 (Placement of amniotic
membrane on the ocular surface; single layer, sutured), which has a
work RVU of 2.50 and CPT code 43252 (Esophagogastroduodenoscopy,
flexible, transoral; with optical endomicroscopy), which has a work RVU
of 2.96. Compared with CPT code 55874, these codes have identical
intraservice and similar total times. We sought comment on whether
these alternative values should be considered, especially given the
changes in time reflected in the survey data.
We received invoices with pricing information regarding two new
supply items: ``endocavity balloon'' and ``biodegradeable material
kit--periprostatic.'' The invoice for the endocavity balloon was
$399.00 and the input price on the PE spreadsheet for this supply item
was noted as such. We believed that the input price noted on the PE
spreadsheet was an error, given that the invoice noted that the price
of $399.00 was for a box of ten and the specialty society requested a
single unit of this supply item. Therefore, we proposed to use this
information to propose for supply item ``endocavity balloon'' a price
of $39.90. The invoice for the ``biodegradeable material kit--
periprostatic'' totaled $2,850.00. We proposed to use this information
to propose for the supply item ``biodegradeable material kit--
periprostatic'' a price of $2850.00. We also received an invoice with
pricing information regarding the new equipment item ``endocavitary US
probe'' which totaled $16,146.00. We proposed to use this information
to propose for equipment item ``endocavitary US probe'', a per-minute
price of $0.0639. We questioned, given an invoice price of $29,999.00
for this existing equipment item EQ250 (portable ultrasound unit),
whether this equipment item includes probes. We sought public comments
related to
[[Page 53053]]
whether equipment item EQ250 (portable ultrasound) includes probes.
Comment: In general, commenters were supportive of our proposal of
the RUC-recommended work RVUs. Some commenters expressed opposition to
the alternative work RVUs we considered.
Response: We are appreciative of the commenters' feedback. We
continue to welcome information from all interested parties regarding
valuation of services for consideration through our rulemaking process.
We will continue to consider alternative work RVUs as we propose the
valuation of services for future notice and comment rulemaking.
Comment: The RUC stated that CMS acknowledges that physician work
intensity per minute is not typically linear and also that making
reductions to RVUs in strict proportion to changes in time is
inappropriate. The RUC further noted that for several comment periods
they have laid out a compelling case to justify this position on work
intensity per minute. They noted that they appreciate CMS's agreeing
with the RUC's assertion that the usage of time ratios to reduce work
RVUs is typically not appropriate, as often a change in the work time
coincides with a change in the work intensity per minute.
Response: We do not agree with the commenter's characterization of
our statements. We stated in the CY 2017 PFS final rule (81 FR 80273)
that we are not implying that the decrease in time as reflected in
survey values must necessarily equate to a one-to-one or linear
decrease in newly valued work RVUs, given that intensity for any given
procedure may change over several years or within the intraservice
period. Nevertheless, we believe that since the two components of work
are time and intensity, absent an obvious or explicitly stated
rationale for why the relative intensity of a given procedure has
specifically increased or that the reduction in time is
disproportionally from less intensive portions of the procedure,
significant decreases in time should generally be reflected in
decreases to work RVUs.
Comment: The RUC noted that they wanted to remind CMS of its and
the RUC's longstanding position that treating all components of
physician time as having identical intensity is incorrect, and
inconsistently applying this treatment to only certain services under
review creates inherent payment disparities in a payment system that is
based on relative valuation. The commenter stated that when physician
times are updated in the fee schedule, the ratio of intraservice time
to total time, the number and level of bundled post-operative visits,
the length of pre-service, and the length of immediate post-service
time may all potentially change for the same service. These changing
components of physician time result in the physician work intensity per
minute often changing when physician time also changes, and the
commenters recommended that CMS always account for these nuanced
variables. The RUC highlighted that their recommendations now
explicitly state when physician time has changed and address whether
and to what magnitude these changes in time impact the work involved.
Response: We stated in the CY 2017 PFS final rule (81 FR 80275)
that we understand that not all components of physician time have
identical intensity and are mindful of this point when determining what
the appropriate work RVU values should be. We agree that the nuanced
variables involved in the changing components of physician time must be
accounted for, and it is our goal to do so when determining the
appropriate valuation. We appreciate when the RUC recommendations
provide as much detailed information regarding the recommended
valuations as possible, including thorough discussions regarding
physician time changes and how the RUC believes such changes should or
should not impact the work involved, and we consider that information
when conducting our review of each code.
Comment: The RUC noted that its support of the proposed refinements
for EF031, EQ250, EQ386, ER061, ER062, and L037D, was contingent on the
assumption that the proposed PE refinements were because of the change
in time for the clinical labor task, ``Obtain vital signs''.
Response: The proposed PE refinements for EF031, EQ250, EQ386,
ER061, ER062, L037D, are a result of our proposal to refine the L037D
clinical labor time for ``Obtain vital signs'' from 3 minutes to 5
minutes, to conform to the proposed standard for this clinical labor
activity. As a result, we proposed to refine the equipment times for
the power table (EF031) from 63 minute to 65 minutes and from 48
minutes to 50 minutes for the following: Portable ultrasound unit
(EQ250), endocavitary US probe (EQ386), stepper stabilizer, template
(for brachytherapy treatment) (ER061), and stirrups (for brachytherapy
table) (ER062) to reflect the service period time associated with this
code.
Comment: Several commenters, including the RUC, were supportive of
our proposed price updates for the ``endocavity balloon'' (SD325),
biodegradeable material kit--periprostatic'' (SA126), and
``endocavitary US probe'' (EQ386) and urged CMS to finalize the
proposal.
Response: We appreciate the support from commenters.
After consideration of comments received, we are finalizing the
following supply and equipment prices: SD325, at a price of $39.90;
SA126, at a price of $2850.00; and EQ386, at a price of $16,146.00 (a
per-minute price of $0.0639).
Comment: Several commenters, including the RUC, noted that
``portable ultrasound unit'' (EQ250), which has a cost of $29,999.00,
does not include an intracavitary probe. These commenters further noted
that the probe is necessary to perform this procedure and recommended
that both the portable unit and the intracavitary probe be recognized
as direct PE inputs for this service. One commenter included pricing
information in its comment letter, noting that the probe should be
added as an additional direct PE input at a cost of $20,700.
Response: While we appreciate the submission of this pricing
information from the commenter, we are unable to consider this pricing
information for the CY 2018 final rule without documentation of
invoices. We request that commenters submit invoices for pricing
updates and that the invoices contain clear documentation regarding the
item in question: Its name, the CMS supply/equipment code that it
references (if any), the unit quantity if the item is shipped in boxes
or batches, and any other information relevant for pricing. To be
considered for a given year's proposed rule, we generally need to
receive invoices by February. In similar fashion, we generally need to
receive invoices by the end of the comment period for the proposed rule
in order to consider them for the supply and equipment pricing for the
final rule for that calendar year. We note that both the ``endocavitary
US probe'' (EQ386) and ``portable ultrasound unit'' (EQ250) are
included in the PE inputs for this service, which are displayed in the
CY 2018 PFS final rule direct PE input database, available on the CMS
Web site under the downloads for the CY 2018 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
After consideration of comments received, we are finalizing the
work RVUs and direct PE inputs for CPT code 55874 as proposed.
[[Page 53054]]
(23) Colporrhaphy With Cystourethroscopy (CPT Codes 57240, 57250, 57260
and 57265)
In October 2015, CPT code 57240 was identified by analysis of the
Medicare data from 2011-2013 that indicated that services reported with
CPT code 57240 were performed less than 50 percent of the time in the
inpatient setting, yet include inpatient hospital E/M services within
the global period. The RUC recommended that CPT codes 57240 (Anterior
colporrhaphy, repair of cystocele with or without repair of
urethrocele), 57250 (Posterior colporrhaphy, repair of rectocele with
or without perineorrhaphy), 57260 (Combined anteroposterior
colporrhaphy), and 57265 (Combined anteroposterior colporrhaphy; with
enterocele repair) be referred to the CPT Editorial Panel. In September
2016, the CPT Editorial Panel revised CPT codes 57240, 57260 and 57265
to preclude separate reporting of follow up cystourethroscopy after
colporrhaphy (CPT code 52000).
For CY 2018, we proposed the RUC-recommended work RVUs for CPT code
57240 (a work RVU of 10.08), CPT code 57250 (a work RVU of 10.08), CPT
code 57260 (a work RVU of 13.25), and CPT code 57265 (a work RVU of
15.00).
We note that there were changes in service times reflected in the
specialty surveys compared to the RUC-recommended work RVUs for CPT
code 57240. Specifically, we note that the RUC recommended a 48 minute
decrease in total time, compared to the specialty survey total time of
259 minutes. The difference in total time reflected a decrease in
preservice time (29 minutes) and inpatient visits (0.5 visits = 19
minutes). We considered a work RVU of 9.77 for CPT code 57240,
crosswalking to CPT code 50590 (Lithotripsy, extracorporeal shock
wave), which has similar service times. We sought comment on whether
CPT code 57250 would be a relevant comparator for CPT code 57240, based
on the described elements of each service and existing or surveyed
service times, compared to CPT code 57240. We considered a work RVU of
11.47 for CPT code 57260 [we note that in the CY 2018 PFS proposed rule
(82 FR 34000), this was cited as CPT code 57265], crosswalking to CPT
code 47563 (Laparoscopy, surgical; cholecystectomy with
cholangiography) with similar service times. We sought comment on how
an alternative work RVU of 11.47 for CPT code 57260 [we note that in
the CY 2018 PFS proposed rule (82 FR 34000), this was cited as CPT code
57260] would affect relativity among PFS services, and on whether CPT
code 57265 [we note that in the CY 2018 PFS proposed rule (82 FR
34000), this was cited as CPT code 57260] is a relevant comparator for
CPT code 57260 [we note that in the CY 2018 PFS proposed rule (82 FR
34000), this was cited as CPT code 57265], considering differences in
the described procedures and service times.
We proposed the RUC-recommended direct PE inputs for CPT codes
57240, 57250, 57260 and 57265 without refinements.
Comment: In general, commenters were supportive of our proposal of
the RUC-recommended work RVUs. We continue to welcome information from
all interested parties regarding valuation of services for
consideration through our rulemaking process. Some expressed opposition
to the alternative work RVUs we considered.
Response: We will continue to consider alternative work RVUs as we
propose the valuation of services for future notice and comment
rulemaking.
After consideration of comments received, we are finalizing the
work RVUs as proposed. We are finalizing the proposed direct PE inputs
for CPT codes 57240, 57250, 57260 and 57265, without refinement.
(24) Injection of Anesthetic Agent (CPT Code 64418)
CPT code 64418 (Injection, anesthetic agent; suprascapular nerve)
was identified by the AMA through their screen of Harvard-valued codes
with utilization over 30,000. We proposed the RUC-recommended work RVU
of 1.10 and RUC-recommended direct PE inputs without refinement.
Comment: We received one comment that expressed support for CMS'
proposed value.
Response: We appreciate the commenter's support.
After consideration of the comment received that specifically
addressed this code, for CY 2018, we are finalizing a work RVU of 1.10
and the proposed direct PE inputs without refinement for CPT code
64418.
(25) Nerve Repair With Nerve Allograft (CPT Codes 64910, 64911, 64912,
and 64913)
The CPT Editorial Panel created two new Category I CPT codes (64912
and 64913) to report the repair of a nerve using a nerve allograft. CPT
codes 64910 and 64911 were also reviewed as part of this code family.
CPT codes 64912 and 64913 will be placed on the new technology list to
be re-reviewed by the RUC in 3 years to ensure correct valuation and
utilization assumptions.
For CY 2018, we proposed the RUC-recommended work RVUs for the
following codes: A work RVU of 10.52 for CPT code 64910, a work RVU of
14.00 for CPT code 64911, a work RVU of 12.00 for CPT code 64912, and a
work RVU of 3.00 for CPT code 64913.
We noted a decrease in preservice time (7 minutes) for CPT code
64910 and considered an alternate work RVU of 10.15, crosswalking to
CPT code 15120 (Split-thickness autograft, face, scalp, eyelids, mouth,
neck, ears, orbits, genitalia, hands, feet, and/or multiple digits;
first 100 sq cm or less, or 1 percent of body area of infants and
children (except 15050)), which has similar service times. We sought
comments on whether an alternative work RVU of 10.15 for CPT code 64910
would better reflect relativity among PFS services with similar service
times.
For CPT code 64911 (Nerve repair; with autogenous vein graft
(includes harvest of vein graft), each nerve)), we considered a work
RVU of 13.50, by crosswalking to CPT code 31591 (Laryngoplasty,
medicalization, unilateral), which has similar service times and a work
RVU of 13.56. We sought comments on whether a work RVU of 13.50 for CPT
code 64911 would better reflect relativity among other PFS services
with similar service times.
The new coding structure for these services increases granularity
by including add-on codes that describe each strand of nerve repair.
While we recognize that additional granularity may be important and
useful for purposes of data collection, the advantages to Medicare for
such granularity for purposes of payment are unclear, especially since
we are unaware of a payment-related reason for such coding complexity.
We considered proposing a bundled status to the new add-on codes and
incorporating the relative resources in furnishing the add-on code (CPT
code 64913) into the base code (CPT code 64912) based on the
utilization assumptions that accompanied the RUC's recommendations. The
RUC estimated that CPT code 64912 would have 750 Medicare allowed
services in CY 2018, and that the corresponding add-on CPT code 64913
would have 150 Medicare allowed services in CY 2018. Therefore, the RUC
estimated that CPT code 64912 will be billed without add-on CPT code
64913 for 80 percent (750/900) of the Medicare allowed services, and
that CPT code 64912 will be billed with add-on CPT code time 64913 for
20 percent (150/900) of the Medicare allowed services in CY 2018. To
account for the additional work involved in 20 percent of the allowed
services, we added a
[[Page 53055]]
work RVU of 0.60 (20 percent of the work RVU of 3.00 for CPT code
64913) to the work RVU of 12.00 for CPT code 64912, to derive an
alternative work RVU of 12.60 for CPT code 64912 and increased the
intraservice time by 6 minutes to account for the bundling of services
from CPT code 64913. The alternative work RVU of 12.60 would have been
further supported by a crosswalk to CPT code 14301 (Adjacent tissue
transfer or rearrangement, any area; defect 30.1 sq cm to 60.0 sq cm),
which has similar intraservice and total times.
We proposed the RUC-recommended direct PE inputs for CPT codes
64910, 64911, 64912 and 64913 without refinements.
Comment: In general commenters were supportive of our proposal of
the RUC-recommended work RVUs. Some expressed opposition to the
alternative work RVUs.
Response: We will continue to consider alternative work RVUs as we
propose the valuation of services for future notice and comment
rulemaking.
Comment: Some commenters disagreed with our proposal to bundle CPT
codes 64912 and 64913. Several commenters, including the RUC, noted
that bundling the service would place a financial burden on the
patients who do not require multiple strands because they would be
charged 120 percent of what they should be charged. One commenter cited
this as the payment-related reason to not bundle the services, and
further noted that bundling would undermine the premise of coding and
relative reimbursement. The RUC noted that CPT code 64913 is an add-on
code for the additional work related to insertion of an additional
nerve allograft for the same nerve. They stated that the additional
work is not typically performed with the base code and therefore would
not be appropriate to bundle into the work of the base code.
Response: We note that section 1848(c)(2)(K)(iii)(V) of the Act
specifies that the Secretary may make appropriate coding revisions
(including using existing processes for consideration of coding
changes) that may include consolidation of individual services into
bundled codes for payment under the physician fee schedule. We will
continue to consider these options as we propose the valuation of
services for future notice and comment rulemaking.
Comment: The RUC stated that it is atypical for CMS to question the
coding structure of newly proposed services via rulemaking. In the
future, they requested that CMS voice concerns regarding coding
structure as part of the agency's participation in the CPT Editorial
Panel review process.
Response: While we acknowledge that the discussion and
consideration of different coding structures occurs during the CPT
Editorial Panel review process, we also note that not all interested
parties have the opportunity to participate in the CPT Editorial Panel
review process, and not all relevant stakeholders are members of the
CPT Editorial Panel. Additionally, we would like to reiterate that,
while we appreciate that some commenters believe that CMS staff could
offer useful perspectives by regularly attending and participating more
fully in the CPT Editorial Panel review process, we do not believe that
would be appropriate for many reasons, not least of which is that CMS
staff participation in the CPT Editorial Panel review process cannot
supplant our obligation to establish through notice and comment
rulemaking what we determine to be appropriate coding structures for
each reviewed code. Accordingly, we disagree with the commenter's
suggestion that CMS staff should preemptively address the concerns of
coding structures during the CPT Editorial Panel review process,
instead of through notice and comment rulemaking. Formal notice and
comment rulemaking allows all interested parties the opportunity to
review our proposals and provide feedback, as well as to submit
supplemental information about our proposals, and address any concerns
or alternatives we have expressed in making our proposal.
Comment: A commenter questioned why CMS would be concerned with a
code pair that is not typically reported for Medicare-aged patients,
but instead is a service for younger patients that have better nerve
healing capacity.
Response: As discussed in the CY 2017 PFS final rule (82 FR 80172),
the statute requires us to establish, by regulation, each year's
payment amounts for all physicians' services paid under the PFS.
Although we prioritize high volume services when we routinely examine
the valuation and coding for existing services under the misvalued code
initiative, we also value low-volume services in accordance with the
statute.
After consideration of comments received, we are finalizing the
work RVUs for CPT codes 64910, 64911, 64912, and 64913 as proposed. We
are also finalizing the proposed direct PE inputs for these codes,
without refinement.
(26) Correction of Trichiasis (CPT Code 67820)
In CY 2016, CPT code 67820 was identified by the screen for high
expenditure services across specialties with Medicare allowed charges
of $10 million or more. The screen identified the top 20 codes by
specialty in terms of allowed charges, excluding 10- and 90-day global
services, anesthesia and E/M services and services reviewed since CY
2010. During the review process, the RUC re-surveyed the code and
recommended a work RVU of 0.32, which we proposed in the CY 2018 PFS
proposed rule.
The RUC also recommended 15 minutes of preservice time in the
facility setting to complete preservice diagnostic and referral forms,
coordinate pre-surgery services, schedule space and equipment in the
facility, provide preservice education/obtain consent, and follow-up
phone calls and prescriptions. We believed it to be atypical for a
physician's staff to be performing these activities in a facility-
setting with a procedure that has a 0-day global period. Therefore, we
proposed removing the time associated with these activities.
We also note that in the course of refining the times associated
with the clinical activities referenced above, we inadvertently reduced
the time associated with the screening lane (EL006) from 11 minutes to
5 minutes.
Comment: Commenters stated that a default policy of allowing zero
minutes of preservice time in the facility setting was inappropriate as
ambulatory practices often expend staff time to coordinate with the
facility in order to bring their patients in to perform procedures.
Commenters also acknowledged that it may be atypical for epilation of
eyelashes to require pre-surgery coordination, follow-up phone calls or
prescriptions and that by removing these two activities, the total
clinical staff preservice time would be more appropriate for the
service.
Response: We appreciate the information provided by commenters
regarding the preservice clinical activities and agree that certain
activities are typical for this service. Therefore, for CY 2018, we
will finalize a total of 9 minutes of preservice time which corresponds
with coordinating pre-surgery services, scheduling space and equipment
in the facility, and providing preservice education/obtain consent.
Comment: Commenters stated their disagreement with the reduction of
time from 11 to 5 minutes for the screening lane (EL006), as the
physician would be
[[Page 53056]]
treating the patient in the screening lane for all aspects of the
procedure and therefore, it would be unavailable for any other use
during the procedure.
Response: As we stated above, we inadvertently reduced the time of
the screening lane and did not intend to make a proposal regarding this
equipment item. Therefore, for CY 2018, we will finalize the RUC-
recommended 11 minutes for the screening lane.
Comment: Another commenter expressed their support for the RUC
process, but opposed the RUC-recommended work RVU of 0.32 for CPT code
67820. The commenter recommended CMS increase the work RVU to the 0.40
to align with 25th percentile of the survey.
Response: We believe the RUC's recommend valuation of 0.32 for CPT
code 67820 is appropriate due to the overall reduction in total time
and it having less intensity than its key reference code, CPT code
11900, Injection, intralesional; up to and including 7 lesions (work
RVU = 0.52, intra time = 8 minutes). Therefore, after consideration of
the comments, we will finalize the RUC-recommended work RVU of 0.32 for
CPT code 67820 for CY 2018.
(27) CT Soft Tissue Neck (CPT Codes 70490, 70491, and 70492)
CPT codes 70490 and 70492 were identified through the high
expenditure services across specialties with Medicare allowed charges
of $10 million or more screen. CPT code 70491 was also included for
review as part of this code family. For CY 2018, we proposed the RUC-
recommended work RVUs of 1.28 for CPT code 70490, 1.38 for CPT code
70491, and 1.62 for CPT code 70492. For CPT code 70490, we considered a
work RVU of 1.07 based on a crosswalk to CPT code 72125 (Computed
tomography, cervical spine; without contrast material). CPT code 72125
is a non-contrast CT service on a similar anatomical area and has
identical intraservice and total times to those recommended by the RUC
for CPT code 70490. We also considered work RVUs of 1.17 for CPT code
70491 and 1.41 for CPT code 70492. We sought comment on how relativity
among other CT services paid under the PFS would be affected by
applying the alternative work RVUs described above for CPT codes in
this family.
Comment: Commenters disagreed with our alternative values and
supported our proposal to implement the RUC-recommended values.
Response: We appreciate the comments regarding our proposals.
After consideration of the public comments, we are finalizing the
RUC-recommended work RVUs as proposed.
(28) Magnetic Resonance Angiography (MRA) Head (CPT Codes 70544, 70545,
and 70546)
CPT code 70544 was identified by a screen of services across
specialties with Medicare allowed charges of $10 million or more.
Subsequently, CPT codes 70545 and 70546 were also reviewed as part of
this code family. We proposed the RUC-recommended work RVUs of 1.20 for
CPT code 70544, 1.20 for CPT code 70545, and 1.48 for CPT code 70546.
We also proposed the following refinements to the RUC-recommended
direct PE inputs. For the service period clinical labor activity
``Provide preservice education/obtain consent,'' we proposed 5 minutes
for CPT code 70544, 7 minutes for CPT code 70545, and 7 minutes for CPT
code 70546 so that the times for this activity are consistent with
other magnetic resonance (MR) services performed without-contrast
materials, with-contrast materials, and without-and-with contrast
materials, respectively. For the clinical labor task ``Acquire
images,'' we proposed using the RUC-recommended clinical time of 26
minutes for CPT code 70544. We considered proposing 20 minutes of
clinical time to maintain the relativity among the three codes in this
family and for consistency with other MRA and magnetic resonance
imaging (MRI) codes, which do not typically assign more clinical labor
time to this task for services without contrast material than for
services with contrast material. We sought comment as to the
appropriate time value for this clinical labor task. For the clinical
labor task ``Technologist QCs images in PACS, checking all images,
reformats, and dose page,'' we proposed to refine the clinical labor
time from the RUC recommended 4 minutes to 3 minutes to comply with the
standards.
Comment: A commenter disagreed with our proposed clinical labor
time for the task ``Technologist QCs images in PACS, checking all
images, reformats, and dose page,'' and stated that CMS had previously
determined that the amount of clinical labor needed to check images in
a PACS workstation may vary depending on the service, and that CMS
would agree to times above the standard if a compelling rationale is
presented.
Response: We believe that MRA services are analogous to MRI
services in that they are most accurately considered procedures of
intermediate complexity.
Comment: One commenter did not agree with our alternative value for
the clinical labor task ``acquire images.''
Response: We appreciate the comment, and we are finalizing as
proposed the RUC-recommended clinical labor time value for this task.
After consideration of the comments, we are finalizing these PE
refinements as well as the RUC-recommended work RVUs, as proposed.
(29) Magnetic Resonance Angiography (MRA) Neck (CPT Codes 70547, 70548,
and 70549)
CPT code 70549 was identified through a high expenditure screen.
CPT codes 70547 and 70748 were also reviewed as part of this family of
codes. We proposed the RUC-recommended work RVUs of 1.20 for CPT code
70547, 1.50 for CPT code 70548, and 1.80 for CPT code 70549. We also
proposed several refinements to the RUC-recommended direct PE inputs
for these services. For the service period clinical labor activity
``Provide preservice education/obtain consent,'' we proposed 5 minutes
for CPT code 70547, 7 minutes for CPT code 70548, and 7 minutes for CPT
code 70549 so that the times for this activity are consistent with
other MR services performed without contrast material, with contrast
material, and without-and with contrast material, respectively. For the
intraservice clinical labor task acquire images, for CPT code 70547, we
proposed to use the RUC-recommended 26 minutes. We considered applying
20 minutes to this clinical labor task, which would have maintained
consistency with the 20 minutes recommended by the RUC for CPT code
70548 (the service that includes with-contrast material). We stated
concern about the lack of evidence that a non-contrast MRA would
require more clinical labor time than the with-contrast MRA service. We
sought comment as to the appropriate time value for this clinical labor
task. For the clinical labor task ``Technologist QCs images in PACS,
checking all images, reformats, and dose page,'' we proposed to refine
the clinical labor time from the RUC recommended 4 minutes to 3 minutes
to comply with the standards.
Comment: A commenter did not agree with our alternative time value
for the task ``acquire images.''
Response: We appreciate the comment, and we are finalizing the RUC-
recommended time value for this clinical labor task as proposed.
Comment: A commenter disagreed with our proposed clinical labor
time for the task ``Technologist QCs images in PACS, checking all
images, reformats,
[[Page 53057]]
and dose page,'' stating that CMS had previously determined that the
amount of clinical labor needed to check images in a PACS workstation
may vary depending on the service, and that we will agree to times
above the standard if a compelling rationale is presented.
Response: We believe that MRA services are analogous to MRI
services in that they are most accurately considered procedures of
intermediate complexity. Therefore, for CPT codes 70547, 70548, and
70549, we are finalizing these PE refinements as well as the RUC-
recommended work RVUs, as proposed.
(30) CT Chest (CPT Codes 71250, 71260, and 71270)
CMS identified this code family through the high expenditures
screen. We proposed the RUC-recommended work RVUs of 1.16 for CPT code
71250, 1.24 for CPT code 71260, and 1.38 for CPT code 71270. For CPT
code 71250, we considered maintaining the CY 2017 work RVU of 1.02. We
stated that we are concerned with the lack of evidence that the
physician time or intensity of furnishing this service has changed
since it was last valued. In addition, we noted that a comparison to
other CT codes indicated that the RUC-recommended work values could be
overvalued relative to other CT services and compared to similar, non-
contrast CT studies such as CPT codes 72131 (Computed tomography,
lumbar spine; without contrast material) and 73700 (Computed
tomography, lower extremity; without contrast material), both of which
have work RVUs of 1.00. For CPT code 71260, we considered proposing a
work RVU of 1.10 by applying the RUC-recommended increment between CPT
code 71250 and 71260 (0.08) to CPT code 71260. For CPT code 71270, we
considered a work RVU of 1.24 by applying the RUC-recommended increment
between CPT codes 71260 and 71270 (0.22) to CPT code 71270. In addition
to maintaining relatively among the codes in this family, we considered
further supporting these alternative values based on a comparison to
other CT studies, such as with-contrast material CT studies, and
without-and-with contrast CT studies. While noting our concerns, we
proposed the RUC recommended work RVUs for CPT code 71250, 71260, and
71270 and sought comment on whether our alternative values would
improve relativity.
Comment: Commenters supported the proposed values for these codes
but disagreed with the alternative values.
Response: We appreciate the comments in support of our proposals.
After consideration of the public comments, we are finalizing the
RUC-recommended values as proposed.
(31) MRI of Abdomen and Pelvis (CPT Codes 72195, 72196, 72197, 74181,
74182, and 74183)
CPT codes 74182 and 72196 were identified as part of the screen of
high expenditure services across specialties with Medicare allowed
charges of $10 million or more. CPT codes 74181, 74183, 72195, and
72197 were also reviewed as part of this code family. We proposed the
RUC-recommended work RVUs of 1.46 for CPT code 72195, 1.73 for CPT code
72196, 2.20 for CPT code 72197, 1.46 for CPT code 74181, 1.73 for CPT
code 74182, and 2.20 for CPT code 74183. While we proposed the RUC-
recommended direct PE inputs, we considered 30 minutes for clinical
labor task ``Acquire images'' for CPT codes 74181 and 74182, which we
stated appeared to be more consistent with the codes in this family and
more consistent with other MR codes. We also noted that for CPT codes
74181 and 74182, the clinical labor time for acquired images appears to
have been developed through a consensus panel from the specialty
society over 15 years ago. Given that these times are estimates based
on expert panel consensus rather than survey data, we sought comment on
whether using a structure that matches other MR code families would be
more appropriate to value these clinical labor times.
Comment: A commenter stated that all clinical labor time inputs are
based on an expert panel, and our expression of concern for this code
family is thus inconsistent with our review of other services in
current and past rulemaking.
Response: We appreciate the comment and we are finalizing the RUC-
recommended work RVUs, as proposed.
(32) MRI Lower Extremity (CPT Codes 73718, 73719, and 73720)
CPT codes 73718 and 73720 were identified as part of the screen of
high expenditure services, and CPT code 73719 was included for review
as part of the code family. We proposed the RUC-recommended work RVUs
of 1.35 for CPT code 73718, 1.62 for CPT code 73719, and 2.15 for CPT
code 73720. We are also proposing the following refinements to the RUC-
recommended direct PE inputs. For the service period clinical labor
activity ``Provide preservice education/obtain consent,'' we proposed 5
minutes for CPT code 73718, 7 minutes for CPT code 73719, and 7 minutes
for CPT code 73720. Likewise, for the service period task ``Prepare
room, equipment, supplies,'' we proposed 3 minutes for CPT code 73718,
5 minutes for CPT code 73719, and 5 minutes for CPT code 73720. We
proposed these changes to maintain consistency with other MR services
without contrast materials, with contrast materials, and without-and-
with contrast materials, respectively.
Comment: A commenter disagreed with our proposed PE refinements to
the clinical labor activity ``Prepare room, equipment, supplies,''
stating that the RUC-recommended clinical labor time paralleled other
recent MRI codes, including MRI brain and MRI face, and that MR
involves strong magnetic fields and ensuring patient safety is
important. More specifically, all objects in the room must be MRI
compatible. MR exams involve the use of MR coils which vary based on
the body part studied and are specifically selected to fit the patient.
These coils must be prepared for the intended exam, positioned, and
attached to the MR unit. In addition, the examinations involving the
use of contrast require setup of the injector apparatus and preparation
of the contrast material.
Response: We agree that the RUC-recommended clinical labor times
for this activity appear consistent with those for the code family
mentioned by the commenter. Therefore, we are not finalizing our
proposed time values for this activity, and are instead finalizing the
RUC-recommended values of 5 minutes, 7 minutes, and 7 minutes for CPT
codes 73718, 73719, and 73720, respectively, to maintain consistency
among similar services.
(33) Abdominal X-Ray (CPT Codes 74022, 74018, 74019, and 74021)
CPT codes 74000 (Radiologic examination, abdomen; single
anteroposterior view) and 74022 (Radiologic examination, abdomen;
complete acute abdomen series, including supine, erect, and/or
decubitus views, single view chest) were identified via a high
expenditure screen. The CPT Editorial Panel created CPT codes
7401874018, 7401974019, and 7402174021to replace CPT codes 74000,
74010, and 74020. The RUC suggested a utilization scenario that assumes
that 25 percent of services currently reported with CPT code 74010 will
be reported with CPT code 74019 and 75 percent will be reported with
CPT code 74021; and 75 percent of services currently reported with CPT
code 74020 will be reported with CPT code 74019 and 25 percent will be
reported with CPT code 74021. In the CY 2018 PFS proposed rule, we
stated that we did not identify evidence or a rationale for these
assumptions. For
[[Page 53058]]
purposes of calculating the proposed RVUs, we used an even distribution
of services previously reported as CPT codes 74010 and 74020 to CPT
codes 740X2 and 740X3 instead of the RUC-recommended distribution
because we thought that the services previously reported with codes
74010 and 74020 will be reported in equal volume between the code
representing two views and the code representing three views, and we
sought comment on information that would help us improve on this
distribution for purposes of developing final RVUs, including rationale
for the distribution reflected in the RUC's utilization crosswalk.
Comment: The RUC commented that its utilization assumptions are
based on expert panel consensus, and said that its utilization
assumptions will result in savings that would be reapplied to the
Medicare conversion factor. The RUC also requested clarity regarding
our utilization assumptions and their relationship to the work RVUs we
proposed for this code family.
Response: We appreciate the RUC's input regarding utilization
assumptions. We note that we are finalizing the RUC-recommended work
RVUs as proposed, and our utilization assumptions do not determine the
valuation of work RVUs, which will be incorporated into overall budget
neutrality calculations.
(34) Angiography of Extremities (CPT Codes 75710 and 75716)
This code family was identified through the $10 million or more
screen of high expenditure services. We proposed the RUC-recommended
work RVUs of 1.75 for CPT code 75710 and 1.97 for CPT code 75716. We
also proposed to use the RUC-recommended direct PE inputs for CPT codes
75710 and 75716, with the following refinements. For the clinical labor
task ``Technologist QC's images in PACS, checking for all images,
reformats, and dose page,'' we proposed refinements consistent with the
standard clinical labor times for tasks associated with the PACS
Workstation. We also proposed to refine the clinical labor by removing
the 2 minutes associated with the task ``prepare room, equipment, and
supplies.'' CPT codes 75710 and 75716, which represent radiological
supervision and interpretation, are billed with codes that include
activities such as needle placement and imaging, and the ``prepare
room, equipment, supplies,'' activity will be accounted for with the
codes that are billed with these interpretation codes.
Comment: A commenter disagreed with our proposed clinical labor
time for the task ``Technologist QCs images in PACS, checking all
images, reformats, and dose page,'' stating that CMS had previously
determined that the amount of clinical labor needed to check images in
a PACS workstation may vary depending on the service, and that we would
agree to times above the standard if a compelling rationale is
presented.
Response: We believe that MRA services are analogous to MRI
services in that they are most accurately considered procedures of
intermediate complexity.
After consideration of the comment we received, we are finalizing
these PE refinements as well as the RUC-recommended work RVUs, as
proposed.
(35) Ophthalmic Biometry (CPT Codes 76516, 76519, and 92136)
In the CY 2016 PFS final rule with comment period, CMS identified
CPT codes 76519 and 92136 as potentially misvalued on the high
expenditure screen. For CY 2018, we proposed the RUC-recommended work
RVUs for each code in this family as follows: 0.40 for CPT code 76516,
0.54 for CPT code 76519, and 0.54 for CPT code 92136.
For CPT codes 76519 and 92136, the RUC recommended adding an
additional 8 minutes of immediate postservice time for dictating the
report of the procedure for the medical record, review and sign report,
communicate results to the patient, discussing lens implant options for
desired postoperative refractive result, and entering an order for the
intraocular lens implant. We considered time and work values that would
not include the additional 8 minutes of immediate postservice time in
either of these codes, due to the concern that the additional time may
not reflect the typical case. Were we to not include those 8 minutes,
each of these procedures would have a total time of 14 minutes. We
considered applying the total time ratio (decrease from 17 minutes to
14 minutes; ratio of 0.824) to the RUC-recommended work RVU of 0.54,
which would have resulted in a work RVU of 0.44 for CPT codes 76519 and
92136. We sought comment on whether these alternative values would
improve relativity.
Comment: Several commenters, including the RUC, stated the
additional immediate postservice time for CPT codes 76519 and 92136 was
appropriate due to the need for the provider to discuss the multiple
lens options and refractive outcomes with the patient; as many of these
medical options were not available when the code was last surveyed.
Response: We appreciate the feedback from the commenters regarding
the relativity of our alternative value. After considering these
comments, we are finalizing the RUC-recommended values of 0.54 RVUs for
CPT codes 76519 and 92136, for CY 2018.
(36) Ultrasound of Extremity (CPT Codes 76881 and 76882)
The RUC identified CPT codes 76881 and 76882 for review only of PE
inputs. For CPT code 76881, we proposed the RUC-recommended inputs with
refinements. We proposed to remove 1 minute from the clinical labor
task ``Exam documents scanned into PACS. Exam completed in RIS system
to generate billing process and to populate images into Radiologist
work queue,'' because this code does not include any equipment time for
the PACS workstation proxy or professional PACS workstation. We noted
that the RUC-recommended inputs shift the general ultrasound room from
the PE inputs for CPT code 76881 to the PE inputs for CPT code 76882.
We proposed to make this change, consistent with the RUC
recommendations; however, we sought comment on whether a portable
ultrasound unit would be a more accurate PE input for both codes, given
that the dominant specialty for both of these services is podiatry,
based on available 2016 Medicare claims data. As noted in the CY 2018
PFS proposed rule, we proposed that these codes would not be subject to
the phase-in of significant RVU reductions given the significance of
this shift of resource costs between codes in the same family and
sought comment on this proposed application of the phase-in policy.
Comment: Many commenters disagreed with the RUC recommendations for
the direct PE inputs, stating that the shift of PE from CPT code 76881
to CPT code 76882 is based on inaccurate assumptions regarding the
typical equipment used in furnishing these services. These commenters
noted that the equipment used to furnish the two procedures is
identical. These commenters stated that the RUC-recommended direct PE
inputs for CPT code 76881, which were developed based on the assumption
that the dominant specialty furnishing the service is podiatry, do not
reflect the equipment inputs utilized by rheumatologists such as an
ultrasound room and PACS workstation.
Furthermore, these commenters stated that valuing CPT code 76882,
which is the limited ultrasound procedure, at a higher price than CPT
code 76881, which is the complete ultrasound procedure, represents a
rank order anomaly. The RUC disagreed with our statement that podiatry
is the dominant
[[Page 53059]]
specialty for both codes and re-affirmed its recommendation.
Response: Examination of 2016 claims indicates that the dominant
specialty for both codes, when considering the volume of global and TC
services in aggregate, is podiatry. Therefore, we are finalizing the
RUC-recommended direct PE inputs with refinements for CPT code 76881 as
proposed. For CPT code 76882, we are not finalizing our proposal to
include an ultrasound room, and we are instead finalizing the RUC-
recommended equipment, with the exception of the ultrasound room, which
we are replacing with a portable ultrasound unit. This is based on the
RUC's determination, as expressed through its recommendations for CY
2018, that a portable unit is the equipment type that is typical for
podiatry, which is the dominant specialty furnishing CPT code 76882. We
are thus applying the PE inputs that the RUC has determined are typical
for the dominant specialty for both codes in order to maintain
consistency and rank order.
Comment: A commenter requested that CMS reconsider our proposal not
to subject these codes to the phase-in of significant RVU reductions.
Response: The significant RVU reductions that will result from the
PE inputs that we are finalizing comprise a change in resource costs
overall for the code family. This is in contrast to our proposal, which
would have shifted costs within codes of the same family. Therefore, we
are not finalizing our proposal to exempt these codes from the phase-
in, and the reduction in the PE for CPT code 76881 will thus be limited
to 19 percent for the first year. This transition period will allow us
to obtain more stakeholder input on the appropriate PE inputs and
specialty assumptions for these services, and we expect to consider
this input for future rulemaking.
Comment: A commenter disagreed with our decision to remove from CPT
code 76881 the one minute of clinical labor assigned to the task ``Exam
document scanned into PACS. Exam completed in RIS system to generate
billing process and to populate images into Radiologist work queue,''
stating that regardless of whether the service includes a PACS
workstation, there is still documentation to be entered.
Response: The task of entering documentation, when not applied to a
code that includes a PACS workstation as an equipment item, is most
appropriately considered indirect PE; therefore, we are finalizing this
refinement as proposed.
(37) Flow Cytometry Codes (CPT Codes 88184 and 88185)
The flow cytometry interpretation family of codes is split into a
pair of codes used to describe the technical component of flow
cytometry (CPT codes 88184 and 88185) that do not have a work
component, and a trio of codes (CPT codes 88187, 88188, and 88189) that
do not have direct PE inputs, as they are professional component only
services. CPT codes 88184 and 88185 were reviewed by the RUC in April
2014, and their CMS-refined values were included in the CY 2016 PFS
final rule with comment period. These codes were reviewed again at the
January 2016 RUC meeting, and new recommendations were submitted to CMS
as part of the CY 2017 PFS rulemaking cycle. In the CY 2017 PFS final
rule (81 FR 80325), we finalized all of the direct PE inputs for CPT
codes 88184 and 88185, as proposed, except for the proposed refinement
to the dye sublimation printer.
As discussed in the potentially misvalued services section of this
final rule (section II.E), we have received conflicting information
about the direct PE inputs for CPT codes 88184 (Flow cytometry, cell
surface, cytoplasmic, or nuclear marker, technical component only;
first marker) and 88185 (Flow cytometry, cell surface, cytoplasmic, or
nuclear marker, technical component only; each additional marker).
Therefore, in the CY 2018 PFS proposed rule, we proposed these codes as
potentially misvalued so that they can be reviewed again because some
stakeholders have suggested the clinical labor and supplies that were
previously finalized are no longer accurate. In response to the CY 2018
PFS proposed rule, several commenters urged CMS to use the RUC's
recommendations for CY 2017 in developing final PE RVUs for these
services instead of recommending additional review under the misvalued
code initiative. Based on this suggestion from the commenters, which
appears to reflect a broad consensus, we have re-examined the CY 2017
RUC-recommended direct PE inputs for these services, in light of the
specific comments. In the paragraphs below, we summarize the direct PE
inputs that we are changing based on these comments.
Comment: Several commenters urged CMS to use the RUC-recommended 15
minutes for the clinical labor activity ``Instrument start-up, quality
control functions, calibration, centrifugation, maintaining specimen
tracking, logs and labeling.'' from CY 2017 for this clinical labor
activity. Commenters stated that the CMS comparison to CPT code 88182
was not appropriate, as that code uses older/simpler technology, and
that the more robust testing described in these codes requires a higher
level of skill, experience, and continuing education in the laboratory
staff than in CPT code 88182.
Response: After reviewing this additional information, we agree
with the commenters that 15 minutes would be typical for this task. We
are finalizing a clinical labor time of 15 minutes for the ``Instrument
start-up, quality control functions . . .'' clinical labor activity for
CPT code 88184.
Comment: Several commenters stated that the RUC-recommended time of
10 minutes for ``Load specimen into flow cytometer, run specimen,
monitor data acquisition, and data modeling, and unload flow
cytometer'' activity for CPT code 88184 reflects the typical case.
Commenters stated that the time it takes for data capture, data
modeling, data acquisition, and computational analysis is significantly
longer for CPT code 88184 than for CPT code 88182, since additional
colors result in more complicated profiles which are more difficult and
time consuming to evaluate.
Response: After reviewing this additional information, we agree
with the commenters that 10 minutes would be typical for this task. We
were persuaded by the additional information that the commenters
supplied regarding the need for extra clinical labor time in CPT code
88184 as compared to CPT code 88182 due to the additional colors used
in flow cytometry. Therefore, we are finalizing a clinical labor time
of 10 minutes for the ``Load specimen into flow cytometer . . .''
clinical labor activity for CPT code 88184.
Comment: Several commenters objected to the finalized supply
quantity of 1 for the flow cytometry antibody (SL186) in CPT codes
88184 and 88185. Commenters stated that although it is standard
practice to use a single antibody multiple times during the analysis,
each antibody or marker can only be billed once per analysis. According
to commenters, multiple uses of such antibodies are not reportable or
billable, but are critical to the overall analysis and interpretation
of results and are part of the total cost for each procedure performed.
A commenter stated that for a typical immunophenotyping panel, it takes
38 units of different antibody reagents to identify 24 distinct cell
surface markers across 10-12 separately analyzed tubes, and therefore a
ratio of 1.6 units of antibody reagent for each reportable and billable
surface marker is required, not
[[Page 53060]]
the 1:1 ratio in the finalized CY 2017 values. All of the commenters
requested using the CY 2017 RUC recommendation of 1.6 supply quantity
for this input.
Response: We appreciate the additional information supplied by the
commenters regarding the flow cytometry antibody (SL186) in CPT codes
88184 and 88185, and in particular the extensive data provided to
explain why the supply quantity of 1.6 would be typical for these
procedures. After reviewing this additional information, we agree with
the commenters and we are finalizing a supply quantity of 1.6 for the
flow cytometry antibody in these two CPT codes.
Comment: Several commenters disagreed with the finalized equipment
time for the dye sublimation printer (ED031). One commenter stated that
printing is not performed all at one time, with 25-30 pages of
information and data printed over a 5-minute time span. One commenter
indicated that this time cannot be linked directly to one particular
clinical labor task line, and the printer cannot be used for any other
task during these 5 minutes even while it is not actively printing, and
urged CMS to adopt the RUC-recommended 5 minutes of equipment time.
Another commenter stated that this process takes usually 10 minutes for
their most technically advanced personnel.
Response: We note that in the CY 2017 PFS final rule, due to the
presentation of new information detailing how the equipment time for
the printer was disassociated from any clinical labor tasks, we
increased the finalized equipment time to the RUC-recommended 5 minutes
for CPT code 88184 and 2 minutes for CPT code 88185. Regarding the
request to increase the equipment time for the dye sublimation printer
to 10 minutes, we have no data to indicate that this amount of
equipment time would be typical. The information that we received from
commenters during the CY 2017 rule cycle, which was again echoed by
additional commenters in this rule cycle, indicated that 5 minutes was
the typical length of time required to print the 25-30 pages of
materials used in this service. The commenter who disagreed and
suggested 10 minutes of equipment time included time for the
pathologist to review the printed materials, and we do not agree that
the printer would typically need to remain in use while the pathologist
conducted this review. We continue to believe that the RUC-recommended
equipment times for the dye sublimation printer would be typical for
these services.
After consideration of the comments received as part of the CY 2018
rule cycle, we are updating the direct PE inputs finalized in CY 2017
for CPT codes 88184 and 88185 with the changes detailed above.
(38) Pathology Consultation During Surgery (CPT Codes 88333 and 88334)
CPT codes 88333 and 88334 were surveyed for both work and PE for
the CY 2018 rule cycle. We proposed the RUC-recommended work RVU of
1.20 for CPT code 88333 and the RUC-recommended work RVU of 0.73 for
CPT code 88334. For the direct PE inputs, we proposed to remove the
clinical labor for the ``Prepare room. Filter and replenish stains and
supplies (including setting up grossing station with colored stains)''
activity from CPT code 88333. This clinical labor is not currently
included in the direct PE inputs for CPT code 88333, and we believed
that this is a form of indirect PE that is not individually allocable
to a particular patient for a particular service. While we agreed that
replenishing stains and supplies is a necessary task, under the
established methodology, we believed that it is more appropriately
classified as indirect PE.
We proposed to refine the clinical labor time for ``Clean room/
equipment following procedure'' activity for CPT code 88333, consistent
with the standard clinical labor time assigned for room cleaning when
used by laboratory services. We sought comments related to the
equipment time assigned to the ``grossing station w-heavy duty
disposal'' (EP015) for CPT codes 88333 and 88334. Although the
recommended equipment time of 10 minutes maintains the current
equipment time assigned to the grossing station, and we had no reason
to believe that this time is incorrect, it was unclear to us how this
equipment time was derived.
Comment: Several commenters stated that the RUC recommended that
CPT code 88334 should have a ZZZ global period rather than a XXX global
period because it is an add-on code and does not include any preservice
or postservice work time. These commenters requested the assignment of
a ZZZ global period for CPT code 88334.
Response: We appreciate the identification of this issue with the
global period for CPT code 88334 from the commenters. Due to a
technical error, a global period of XXX was incorrectly assigned to
this code in the proposed rule. We are finalizing a global period of
ZZZ for CPT code 88334 as the RUC recommended.
Comment: Several commenters disagreed with the proposal to remove
the clinical labor for the ``Prepare room. Filter and replenish stains
and supplies (including setting up grossing station with colored
stains)'' activity from CPT code 88333. One commenter stated that this
was not a form of indirect PE as the clinical labor task was
attributable to a specific patient and constituted a necessary function
of directly providing patients with important lab services. Another
commenter stated that this was not a form of indirect PE because it was
akin to a number of recognized direct PE activity codes such as Prepare
room, equipment and supplies (CA013) and Provide education/obtain
consent (CA011). The commenter stated that to classify these PE
activities as indirect expenses would be unintentionally biased against
pathology and laboratory services, due to their unique status as a
medical specialty in which many procedures can be performed in batches,
serving multiple patients simultaneously.
Response: We continue to believe that many of the activities
described by the clinical labor task ``Prepare room. Filter and
replenish stains and supplies (including setting up grossing station
with colored stains)'' constitute forms of indirect PE. The fact that
many clinical labor tasks associated with pathology and laboratory
services cannot be allocated to individual patients is the reason why
they are classified as indirect PE under our methodology. While some of
these issues may be unique to pathology and laboratory services, in
many other non-lab cases there are also supplies or clinical labor
tasks that are not allocable to individual services that we have
assigned to indirect PE. However, we agree with the commenters that
some of the clinical labor described in this task is analogous to the
clinical labor described in non-laboratory direct PE activity codes
such as Prepare room, equipment and supplies (CA013). Since 2 minutes
is the standard time allocated for the CA013 clinical labor activity
code in non-laboratory services, we will assign 2 minutes for room
preparation and equipment setup for CPT code 88333. We continue to
believe that the replenishing of stains and supplies constitutes a form
of indirect PE, and we do not agree that clinical labor time should be
allocated for this task.
Comment: Several commenters disagreed with the proposal to refine
the clinical labor time for ``Clean room/equipment following
procedure'' activity for CPT code 88333 from 5
[[Page 53061]]
minutes to 1 minute, consistent with the standard clinical labor time
assigned for room cleaning when used by laboratory services. Commenters
stated that they were aware of the existence of this specific standard,
but indicated that they looked to the typical patient scenario as well
as similar services to arrive at a time estimate. The recommended time
of 5 minutes included tasks performed when the add-on CPT code 88334
was also provided.
Response: We continue to believe that the standard clinical labor
time of 1 minute for room and equipment cleaning in laboratory services
should be applied to CPT code 88333, as the commenters did not supply a
rationale as to why this time would not be typical. The RUC's
recommendations for this clinical labor task stated that cleaning the
grossing area was attributable to the first code only (CPT code 88333),
and if there is additional clinical labor required when CPT code 88334
is performed, we believe that it should be included in the direct PE
inputs for that service.
Comment: Several commenters responded to CMS' request for
information regarding the derivation of the recommended equipment time
for the ``grossing station w-heavy duty disposal'' (EP015). Commenters
stated that the time assigned to the EP015 grossing station w-heavy
duty disposal is derived from a combination of the total clinical labor
time for the service and the physician time of reviewing the patient
case at the same grossing station.
Response: We appreciate the additional information from the
commenters regarding the equipment time. As we stated in the proposed
rule, we have no reason to believe that the recommended equipment time
is incorrect, it was simply unclear to us how this equipment time was
derived.
After consideration of comments received, for CY 2018, we are
finalizing the work RVUs and direct PE inputs for the codes in the
pathology consultation during surgery family as proposed, with the
exception of the refinement to the ``Prepare room. Filter and replenish
stains and supplies (including setting up grossing station with colored
stains)'' clinical labor time as detailed above. We are also finalizing
an add-on global period (ZZZ) for CPT code 88334 as the RUC
recommended.
(39) Radiation Therapy Planning (CPT Codes 77261, 77262, and 77263)
CPT code 77263 was identified through a screen of high expenditure
services across specialties. CPT codes 77261 and 77262 were included
for review. For CY 2018, we proposed the RUC-recommended work RVUs of
1.30 for CPT code 77261, 2.00 for CPT code 77262, and 3.14 for CPT code
77263. However, we stated that we had concerns regarding the RUC-
recommended work RVUs given the decreases in service times as
recommended by the RUC and reflected in the survey data compared to the
current values. For CPT code 77263, we considered a work RVU of 2.60
based on a crosswalk to CPT code 96111 (Developmental testing,
(includes assessment of motor, language, social, adaptive, and/or
cognitive functioning by standardized developmental instruments) with
interpretation and report), which has an identical intraservice time,
and similar total time to the RUC-recommended time values for CPT code
77263. We expressed concern that despite a 15 minute decrease in
intraservice time, the RUC did not recommend a work RVU decrease. We
noted that the majority of the utilization among the codes in this
family would be reported with CPT code 77263. Therefore, we considered
using a work RVU of 2.60 for CPT code 77263 as a base for alternative
valuations for CPT codes 77261 and 77262 by applying the ratio of the
crosswalk work RVU of CPT code 96111 (Developmental test extend) to the
RUC-recommended work RVU of CPT code 77263 (that is, 2.60/3.14 = 0.83)
to the RUC-recommended work RVU for CPT code 77261 (that is, 0.83 x
1.30 = 1.08) and CPT code 77262 (that is, 0.83 x 2.0 = 1.66), which
would have resulted in work RVUs of 1.08 for CPT code 77261 and 1.66
for CPT code 77262. We sought comments on whether the alternative
valuation would be more appropriate for these codes.
Comment: Some commenters disagreed with our considered alternative
values, and urged us to adopt the RUC-recommendations as proposed.
Response: We appreciate the feedback from commenters on our
proposal and our alternative values.
After consideration of the comments, we are finalizing the RUC-
recommended work RVUs as proposed.
(40) Tumor Immunohistochemistry (CPT Codes 88360 and 88361)
CPT codes 88360 and 88361 appeared on a high expenditure services
screen across specialties with Medicare allowed charges of over $10
million. We proposed the RUC-recommended work RVU of 0.85 for CPT code
88360 and the RUC-recommended work RVU of 0.95 for CPT code 88361.
We proposed to refine the clinical labor time for the ``Enter
patient data, computational prep for antibody testing, generate and
apply bar codes to slides, and enter data for automated slide stainer''
activity for both codes, consistent with the standard time for this
clinical labor activity across different pathology services. For CPT
code 88361, we also proposed to remove the 1 minute of clinical labor
time from the ``Performing instrument calibration, instrument qc and
start up and shutdown'' and the ``Gate areas to be counted by the
machine'' activities. These clinical labor activities do not appear in
other recently reviewed computer-assisted pathology codes. We believe
that these clinical labor activities would not be typical for CPT code
88361 and are already included in the allocation of indirect PE,
consistent with our established methodology.
We proposed to remove the clinical labor time for ``Clean room/
equipment following procedure'' for CPT codes 88360 and 88361, as we
believed that this clinical labor is duplicative of the 4 minutes of
clinical labor assigned to ``Clean equipment and work station in
histology lab''. We also proposed to remove the clinical labor time for
the ``Verify results and complete work load recording logs'' and the
``Recycle xylene from tissue processor and stainer'' activities for CPT
codes 88360 and 88361. As we stated in previous rules, such as in the
CY 2017 PFS final rule (81 FR 80319), we believed these clinical labor
activities were already included in the allocation of indirect PE,
consistent with our established methodology.
We proposed to refine the equipment time for the ``Benchmark ULTRA
auto slide prep & E-Bar Label system'' (EP112) from 18 minutes to 16
minutes for both codes. The RUC-recommended equipment time of 18
minutes was an increase of 3 minutes from the current EP112 equipment
time to incorporate the equipment time of the ``E-Bar II Barcode Slide
Label System'' (EP113), which the recommended materials have clarified
is part of the EP112 equipment item. We proposed to add 1 minute over
the current value of 15 minutes to the EP112 equipment time to reach
the aforementioned 16 minutes, as we believed that this would be more
typical for the slide labeling taking place.
For CPT code 88361, we proposed to maintain the current price of
$195,000.00 for the DNA image analyzer (EP001) equipment, as the
submitted invoice contained a series of unrelated items that have been
crossed out, making it difficult to determine the cost of the
equipment. We considered refining the equipment time for the DNA image
analyzer from 30 minutes to 5 minutes. The equipment literature for
[[Page 53062]]
the DNA image analyzer states that the machine can run 50 slides per
hour, and CPT code 88361 only requires 3 slides per procedure. This
works out to 3.6 minutes of equipment usage (3 slides divided by 50
slides per hour multiplied by 60 minutes in an hour), to which we
considered adding 1 minute for preparing the slides. The resulting
figure of 4.6 minutes would then round up to 5 minutes, which we
considered as the potential equipment time for EP001 assigned to CPT
code 88361. We sought comments on additional pricing information for
the EP001 DNA image analyzer equipment, specifically, invoices solely
for this equipment containing a rationale for each component part, as
well as the appropriate equipment time typically required for use in
CPT code 88361.
Comment: Several commenters disagreed with our proposal to refine
the clinical labor time for the ``Enter patient data, computational
prep for antibody testing, generate and apply bar codes to slides, and
enter data for automated slide stainer'' activity for both codes from 5
minutes to 1 minute. One commenter stated that this clinical labor task
was unique to immunohistochemistry services and was significantly more
complicated than performance of a hematoxylin and eosin stained section
in the traditional histology laboratory. Another commenter stated that
CMS did not finalize a standardized time for this particular clinical
labor activity in the CY 2017 PFS final rule, and expressed concern
with the reliance on standardized pathology clinical labor tasks and
times. The commenter stated that it would be inappropriate to finalize
this particular refinement since there had not been an opportunity for
stakeholders to comment on the establishment of this standard.
Response: As we stated in the CY 2017 PFS final rule (81 FR 80324),
we agree with the commenters that entering patient data into
information systems is an important task, and we agree that it would
take more than zero minutes to perform. However, we continue to believe
that this is correctly categorized as indirect PE, and therefore, we do
not recognize the entry of patient data as a direct PE input, and we do
not consider this task as typically performed by clinical labor on a
per-service basis.
We also agree with the commenter that we did not finalize a
standard clinical labor time for this particular clinical labor task.
However, we believe that the clinical labor described here under
``generate and apply bar codes to slides'' is broadly analogous to the
clinical labor task ``Complete workload recording logs. Collate slides
and paperwork. Deliver to pathologist'' in CPT codes 88321, 88323, and
88325, which were addressed in the CY 2017 PFS final rule (81 FR 80325-
80326) and were finalized with 1 minute of clinical labor time.
Although we agree that the unique nature of pathology and laboratory
services can make comparisons across codes more difficult than in other
services, we believe the comparison of similar clinical labor
activities across different services is important to maintaining the
relativity of the direct PE inputs. Since we have typically allocated 1
minute to the labeling of slides in other recently reviewed laboratory
services, and we have no reason to believe that CPT codes 88360 and
88361 would not be typical, we are finalizing a clinical labor time of
1 minute for this activity.
Comment: Several commenters disagreed with the proposal to remove
the 1 minute of clinical labor time from the ``Performing instrument
calibration, instrument qc and start up and shutdown'' and the ``Gate
areas to be counted by the machine'' activities from CPT code 88361.
Commenters stated that the fact that these activities do not appear in
other recently reviewed pathology CPT codes should have no bearing on
CPT code 88361, as not all pathology services are identical in terms of
the individual components involved in their execution and many are
unique. Commenters stated that accurate calibration and quality control
are key to accurately measuring the cells and this clinical labor
should be recognized.
Response: We agree with the commenter that there are distinctions
between individual services, and that no two services are identical. We
also believe that comparisons across similar services have an important
role in allowing for greater transparency and consistency, as well as
maintaining the relativity of the direct PE inputs. We are concerned
that too much individual accounting of clinical labor activities, such
as with these two tasks, can lead to PE proliferation, and that this
breakout of activities into numerous subactivities generally tends to
inflate the total time assigned to clinical labor activities and
results in values that are not consistent with the analogous times for
other PFS services. The fact that these clinical labor activities do
not appear in other recently reviewed computer-assisted pathology codes
is noteworthy since it suggests that these tasks were previously
subsumed under other clinical labor activities, rather than being
broken out into individual clinical labor tasks. Instead of listing
``Performing instrument calibration, instrument qc and start up and
shutdown'' and ``Load slides on automatic image analyzer'' as separate
clinical labor tasks, we believe that these activities have
historically been grouped together under more general headings related
to preparation. In other words, we believe that the additional
recommended clinical labor time in this case derives from the separate
listing of these activities as individual tasks rather than
representing a change in practice patterns. We also continue to believe
that these clinical labor activities would not be typical for CPT code
88361 and are already included in the allocation of indirect PE,
consistent with our established methodology.
Comment: Several commenters disagreed with our proposal to remove
the clinical labor time for ``Clean room/equipment following
procedure'' for CPT codes 88360 and 88361. Commenters stated that the
histology laboratory prepares the tissue for sectioning by embedding
the tissue into blocks while the immunohistochemistry laboratory is
typically in a separate and distinct work area. Since these procedures
require both of these work areas to be cleaned, the commenters
requested the restoration of this clinical labor time.
Response: After reviewing this new information, we agree with the
commenters that this clinical labor is not duplicative of the 4 minutes
of clinical labor assigned to ``Clean equipment and work station in
histology lab''. We are finalizing the restoration of this 1 minute of
clinical labor time, as recommended.
Comment: Several commenters disagreed with the proposal to remove
the clinical labor time for the ``Verify results and complete work load
recording logs'' and the ``Recycle xylene from tissue processor and
stainer'' activities for CPT codes 88360 and 88361. Commenters stated
that the time associated with these tasks was a direct expense, not an
indirect cost input, and was allocable to a specific patient. One
commenter indicated that 1 minute was necessary for these tasks in
these services. Another commenter stated that while completion of the
work load reporting logs might be an indirect expense, the quality
control of results is performed for each and every case, and it should
be reported separately as a direct expense.
Response: We appreciate the support from the commenter who agreed
that completion of work load recording logs was a form of indirect PE.
We continue to believe that both of these clinical labor activities are
already included in the allocation of indirect PE consistent
[[Page 53063]]
with our established methodology. Other non-laboratory services conduct
similar administrative activities, such as filling out electronic
health records and recycling supplies, without receiving clinical labor
time for individual services.
Comment: Several commenters disagreed with the proposal to refine
the equipment time for the ``Benchmark ULTRA auto slide prep & E-Bar
Label system'' (EP112) from 18 minutes to 16 minutes for both codes.
Commenters stated that this appeared to be an arithmetic error made
when equipment items EP112 and EP113 were combined, and that there was
a need to add back minutes that had been removed when EP113 was
deleted. The commenters urged CMS to adopt the RUC-recommended EP112
for CPT codes 88360 and 88361, along with CPT codes 88341, 88342, and
88344.
Response: Our proposed value of 16 minutes was not based on an
arithmetic error, as we proposed to add 1 minute over the current value
of 15 minutes to the EP112 equipment time because we believed that 1
minute would be more typical than 3 minutes for the slide labeling
taking place in CPT codes 88360 and 88361. However, after consideration
of the additional evidence supplied by the commenters, we agree that
there should be 3 additional minutes of EP112 equipment time in these
codes as recommended. We were persuaded by the commenters that slide
labeling would indeed take the full 3 minutes of additional time
previously assigned to EP113, rather than the 1 minute that we proposed
to assign for this task. We are finalizing this change to the equipment
time for CPT codes 88360 and 88361, along with a correction to the
total equipment time reclassified as EP112 for the other three codes
mentioned by commenters, as described in Table 11.
Table 11--Benchmark ULTRA Auto Slide Prep & E-Bar Label System (EP112) Equipment Time
----------------------------------------------------------------------------------------------------------------
Total equipment
CPT code Current EP112 Current EP113 time reclassified
minutes minutes as EP112
----------------------------------------------------------------------------------------------------------------
88341.................................................. 15 1 16
88342.................................................. 15 3 18
88344.................................................. 30 3 33
88360.................................................. 15 3 18
88361.................................................. 15 3 18
----------------------------------------------------------------------------------------------------------------
Comment: Several commenters disagreed with the alternative proposal
to refine the equipment time for the DNA image analyzer (EP001) from 30
minutes to 5 minutes. Commenters stated that although the product
literature provides information for 20x and 40x (50 slides/hr.)
however, this is just the initial step in the analytical process of
obtaining an image of the tissue stained for the appropriate antigen.
The commenters stated that it was the additional steps of analysis that
resulted in the RUC recommending 30 minutes of equipment time, and
listed a series of tasks performed by the histotechnologist involving
the EP001 equipment. Commenters stated that 30 minutes of equipment
time is appropriate for the DNA image analyzer. Commenters also
supplied new invoices to address CMS' concerns with the pricing of the
EP001 equipment, and requested a name change from ``DNA image
analyzer'' to ``DNA/digital image analyzer.''
Response: We appreciate the additional information supplied by the
commenters regarding the use of the EP001 equipment.
After consideration of the comments, we are finalizing our proposed
equipment time of 30 minutes instead of the alternative equipment time.
We are finalizing a price of $248,946.30 for this equipment, based on
the submitted price of $258,042.30 minus the price of the user training
($6,800.00), the instructor-led online training ($646.00) and the
shipping and handling costs ($1,650.00). These costs are allocated
through the indirect allocation under the established PE methodology.
We are also finalizing the name change to the EP001 equipment, as
requested by the commenters.
Comment: One commenter recommended a series of clinical labor times
that were higher than the RUC's recommendations. The commenter stated
that these were the average times required to perform the clinical
labor tasks based on their internal time studies.
Response: We are supportive of the submission of additional data
that can aid in the process of determining the resources that are
typically used to furnish these services. However, because we did not
receive data on these specific time studies from the commenter to
support these increases above the RUC recommendations, we are not
incorporating these changes to clinical labor into the tumor
immunohistochemistry codes at this time. We urge interested
stakeholders to consider submitting robust data for these and other
services.
After consideration of comments received, for CY 2018, we are
finalizing the work RVUs for the codes in the tumor
immunohistochemistry family as proposed. We are finalizing the direct
PE inputs for these codes, as proposed, along with the refinements
detailed above in response to the comments.
(41) Cardiac Electrophysiology Device Monitoring Services (CPT Codes
93279, 93281, 93282, 93283, 93284, 93285, 93286, 93287, 93288, 93289,
93290, 93291, 93292, 93293, 93294, 93295, 93296, 93297, 93298, and
93299)
As part of the CY 2016 PFS final rule with comment period (80 FR
70914), several services in this family (reported with CPT codes 93288,
93293, 93294, 93295, and 93296) were identified as potentially
misvalued through the high expenditure by specialty screen. Seven of
the 21 services in this family involve remote monitoring of
cardiovascular devices, and two of these services (reported with CPT
codes 93296 and 93299) are valued for PE only. In the CY 2018 PFS
proposed rule, we proposed the RUC-recommended work RVUs for the 19 CPT
codes in this family that are valued with physician work as follows:
0.65 for CPT code 93279, 0.77 for CPT code 93280, 0.85 for CPT code
93281, 0.85 for CPT code 93282, 1.15 for CPT code 93283, 1.25 for CPT
code 93284, 0.52 for CPT code 93285, 0.30 for CPT code 93286, 0.45 for
CPT code 93287, 0.43 for CPT code 93288, 0.75 for CPT code 93289, 0.43
for CPT code 93290, 0.37 for CPT code 93291, 0.43 for CPT code 93292,
0.31 for CPT code 93293, 0.60 for CPT code 93294, 0.74 for CPT code
93295, 0.52 for CPT code 93297, and 0.52 for CPT code 93298.
For CPT code 93293, we considered a work RVU of 0.91 (25th
percentile survey result) and sought comment on
[[Page 53064]]
whether this alternative work RVU would better maintain relativity
between single and dual lead pacemaker systems and cardioverter
defibrillator services. We considered reducing the work RVU for CPT
code 93282 by 0.11 work RVUs and sought comments on whether this
alternative value would better reflect relativity between the single
and dual lead systems that exist within pacemaker services and within
cardioverter defibrillator services. We also noted that there is a
difference of 0.10 work RVUs between the RUC-recommended values for CPT
codes 93289 and 93282. Therefore, we considered a proportionate
reduction for CPT code 93289 to a work RVU of 0.69. For CPT code 93283,
we considered a work RVU of 0.91, consistent with the 25th percentile
from the survey results, and sought comment on whether this value would
improve relativity.
As noted in this section of the final rule, several of the CPT
codes (99392, 99294, 99295, 99297, and 99298) reviewed by the RUC in
January 2017 involve remote monitoring services for cardiac devices. We
agreed with the RUC that these services are difficult to value
considering that the monitoring duration (number of days between 30 and
90) and the average number of transmissions vary. We also noted that
these codes were surveyed twice, and in both cases the intraservice and
total times were considered by the specialty societies to be
inconsistent with existing times. The RUC explained that it
extrapolated total and intraservice time data for these codes and
warned against making comparisons. Without additional information about
the methods and sources used for extrapolation, however, we had no
basis for assuming the imputed values are of higher quality and/or
accuracy than those from the survey. We did not agree, therefore, that
survey results should not be used as a point of comparison in the
context of other factors, particularly when they are used to support
other considerations.
Although we proposed the RUC-recommended work RVUs for each of
these CPT codes, we considered alternative values. The RUC recommended
a work RVU of 0.31 for CPT code 93293, which is 0.01 work RVUs lower
than the existing work RVU for this code. We have concerns that the
amount of the reduction in the work RVU recommended by the RUC may not
be consistent with the decrease in total time of 7 minutes. We
considered an alternative crosswalk for CPT code 93293 (Pm phone r-
strip device eval) (5 minutes intraservice time and 13 minutes total
time) to CPT code 94726 (Pulm funct tst plethysmograp), which has 5
minutes intraservice time and 15 minutes total time and a work RVU of
0.26. We sought comments on our proposed and alternative valuations for
this code.
For CPT code 93294, we considered a work RVU of 0.55, crosswalking
from CPT code 76706 (Us abdl aorta screen aaa), and sought comments on
whether it would better align with the RUC-recommended service times.
We were concerned that a work RVU of 0.60 may not account for the
difference between existing service times and the RUC-recommended
service times. Similarly, the RUC recommended a work RVU for CPT code
93294 of 0.60, which is 0.05 work RVUs less than the existing work RVU.
The total time for furnishing services reported with CPT code 93294
decreased by 10 minutes, however, and we believe this reduction in time
may not be appropriately reflected by a decrease of 0.05 work RVUs.
Compared to services with similar total and intraservice times, we
identified CPT code 76706 (Us abdl aorta screen aaa) as a potentially
more appropriate crosswalk. CPT code 76706 has identical intraservice
and total service times as CPT code 93294, with a work RVU of 0.55. We
sought comments on whether our alternative value would better reflect
the time and intensity involved in furnishing this service.
For CPT code 93295, we considered a work RVU of 0.69, crosswalking
to CPT code 76586, which has identical intraservice and total times
compared to CPT code 93295. We considered using a work RVU of 0.69 to
maintain the differential between CPT code 93295 and the work RVU we
considered for the previous code in this family (a work RVU of 0.11 for
CPT code 93295). We were concerned about the decrease in service time
compared to the work RVU. We noted that the existing intraservice time
is 22.5 minutes, compared to the RUC-recommended intraservice time of
10 minutes. We sought comments on whether our alternative value would
better reflect the time and intensity involved in furnishing this
service.
For CPT code 93298, the RUC recommended a work RVU of 0.52, which
is unchanged from the current work RVU for this code. We were concerned
about that recommendation given the reduction in both intraservice and
total time for this service. The intraservice time decreased from 24 to
7 minutes, while total time decreased from 44 to 17 minutes. We
acknowledged that the current times for this CPT code and others in
this family are extrapolations. However, without additional information
about the extrapolation of data from survey results, we question
whether the survey results should be excluded from consideration
altogether. We considered a work RVU of 0.37 for CPT code 93297,
crosswalking to CPT code 96446 (Chemotx admn prtl cavity). We also
considered a work RVU of 0.37 for CPT code 93298 based on a crosswalk
to CPT code 96446, since the RUC indicated that the work RVUs for CPT
codes 93297 and 93298 should be the same. We sought comment on our
proposed valuation and whether our alternative valuation would be more
appropriate for this code.
We proposed the RUC-recommended direct PE inputs with the following
refinements. We proposed to remove 2 minutes for ``review charts'' from
CPT codes 93279, 93281, 93282, 93283, 93284, 93285, 93286, 93287,
93288, 93289, 93290, 93291, and 93292 to maintain relativity since it
is not typically incorporated for similar PFS codes. We also proposed
removing 2 minutes for ``complete diagnostic forms, lab & X-ray
requisitions'' for the labor category ``med tech/asst'' (L026A) for
these services because we believe the same activity is being performed
by labor category RN/LPN/MTA (L037D). We sought comments regarding
whether this row was included in error. For the same group of CPT
codes, we also proposed standard refinements for the time for equipment
items EF023 and EQ198.
We proposed to use the RUC-recommended direct PE inputs and times
for all other CPT codes in this family (CPT codes 93293, 93294, 93295,
93296, 93297, 93298, and 93299) without refinement.
Comment: We received several comments requesting that CMS retain
the contractor priced status of the PE-only CPT code 93299. In general,
commenters opposed to the change were concerned that the amount of
payment proposed for this code was too low to adequately reimburse
practitioners.
Response: After reviewing the range of current prices established
by MACs, we agree with concerns that the proposed rate of 0.77 RVUs
corresponds to a low reimbursement relative to the range of payments
across localities and states. We concur that there is no need, at this
time, to establish a national rate, and we defer to individual MACs to
set a reimbursement rate for this CPT code that reflects local
populations, supply costs, and practice patterns. For these reasons, we
are not finalizing our proposal with respect to CPT code 93299, and
this code will remain contractor-priced.
[[Page 53065]]
Comment: We received a comment specifically regarding the proposed
decrease in work RVUs for CPT code 93295 from 1.29 to 0.74. The
commenter maintained that the decrease in work RVUs is inconsistent
with the time requirements and focus on patient care required for
ongoing review of monitoring reports over a 90-day period. The
commenter further noted that the reduction in work RVUs for this code
is inconsistent with a shift in paradigm from an office-based patient
care model to comprehensive care.
Response: We appreciate the commenters' concerns about the RUC-
recommended decrease in work RVUs for this code. However, we note that
the survey conducted by the specialty societies as part of the RUC
process describes a time period of up to 90 days for this code. For
this code, as with many others, these surveys are the best data we have
about the time and intensity of work for a particular CPT code, as well
as the labor time, supplies, and equipment required in furnishing the
service. After consideration of the public comments, we are finalizing
a work RVU of 0.74 for CPT code 93295, as proposed. We are also
finalizing work RVUs for the remainder of the CPT codes in this family
as proposed.
(42) Transthoracic Echocardiography (TTE) (CPT Codes 93306, 93307, and
93308)
In the CY 2016 PFS final rule with comment period (80 FR 70914),
CMS identified CPT code 93306 through the high expenditures screen.
Subsequently, the RUC reviewed CPT codes 93307 and 93308, in addition
to CPT code 93306, as part of this family of codes that describe
transthoracic echocardiograms. In the CY 2018 PFS proposed rule, we
proposed the RUC-recommended work RVUs for CPT codes 93306 (a work RVU
of 1.50), 93307 (a work RVU of 0.92), and 93308 (a work RVU of 0.53),
and proposed the RUC-recommended direct PE inputs for CPT codes 93306,
93307, and 93308 without refinement.
For CPT code 93306 (Echocardiography, transthoracic, real-time with
image documentation (2D), includes M-mode recording, when performed,
complete, with spectral Doppler echocardiography, and with color flow
Doppler echocardiography), we considered maintaining the CY 2017 work
RVU of 1.30. The surveyed total time for this code dropped slightly due
to changes in the immediate postservice time. The median preservice and
intraservice time remained unchanged.
For CPT code 93307 (Echocardiography, transthoracic, real-time with
image documentation (2D), includes M-mode recording, when performed,
complete, without spectral or color Doppler echocardiography), we
considered a work RVU of 0.80, crosswalking to services with similar
service times (CPT codes 93880 (Duplex scan of Extracranial arteries;
complete bilateral study), 93925 (Duplex scan of lower extremity
arteries or arterial bypass grafts; complete bilateral study), 93930
(Duplex scan of upper extremity arteries or arterial bypass grafts;
complete bilateral study), 93976 (Duplex scan of arterial inflow and
venous outflow of abdominal, pelvic, scrotal contents and/or
retroperitoneal organs; limited study), and 93978 (Duplex scan of
aorta, inferior vena cava, iliac vasculature or bypass grafts; complete
study)). The surveyed total time dropped 3 minutes (from the
intraservice time) compared to the existing service times for this
code.
For CPT code 93308 (Echocardiography, transthoracic, real-time with
image documentation (2D), includes M-mode recording, when performed,
follow-up or limited study), we considered a work RVU of 0.43,
crosswalking to CPT code 93292 (Interrogation device evaluation (in
person) with analysis, review and report by a physician or other
qualified health care professional, includes connection, recording and
disconnection per patient encounter; wearable defibrillator system)
based on similar service times. The surveyed total time dropped by 5
minutes (from the intraservice time) compared to the existing service
times for this code.
For CY 2018, we proposed the RUC-recommended work RVUs for CPT
codes 93306, 93307, and 93308 and sought comments on whether our
alternative values would have better reflected the time and intensity
of these services.
Comment: A few commenters addressed the codes in this family
including the RUC. Commenters expressed support for CMS' proposed
values.
Response: We appreciate the commenter's support.
After consideration of the comments received that specifically
addressed this code family, for CY 2018, we are finalizing a work RVU
of 1.50 for CPT code 93306, a work RVU of 0.92 for CPT code 93307, and
a work RVU of 0.53 for CPT code 93308, as proposed. We are also
finalizing the proposed direct PE inputs without refinement for all
codes in this family.
(43) Stress Transthoracic Echocardiography (TTE) Complete (CPT Codes
93350 and 93351)
CPT code 93351 was identified as potentially misvalued and the RUC
reviewed CPT code 93350 as part of the same code family. In the CY 2018
PFS proposed rule, we proposed the RUC-recommended work RVUs for CPT
codes 93350 (a work RVU of 1.46) and 93351 (a work RVU of 1.75).
We proposed the following refinements to the RUC-recommended direct
PE inputs for CPT codes 93350 and 93351. For both codes, we applied the
standard formula in developing the minutes for equipment item ED053
(professional PACS workstation), which results in 18 minutes for CPT
code 93350 and 25 minutes for CPT code 93351. We also proposed standard
clinical labor times for providing preservice education/obtaining
consent. We did not propose to include clinical labor time for the task
setup scope since there is no scope used in the procedure and we did
not agree with the RUC's statement that this replicates 5 minutes in
CPT code 93015 when the RN prepares patients for 10-lead ECG. We found
that there was no corresponding time of 5 minutes for setup scope in
the PE inputs for CPT code 93015. We proposed refinements to the
equipment time for ED050 (PACS workstation proxy) for CPT code 93351,
consistent with our standard equipment times for PACS Workstation
Proxy.
Comment: Commenters generally supported our proposed work RVUs for
CPT codes 93350 and 93351, which are remaining unchanged from CY 2017.
Response: We appreciate the feedback from stakeholders and we are
finalizing work RVUs for these two codes, as proposed.
Comment: Several commenters, including the RUC, disagreed with our
proposed refinements to PE inputs, particularly with regard to changes
in the equipment time to conform to established policies for non-highly
technical equipment and PACS workstations.
Response: We note that these refinements are in accordance with the
standards and formulas for equipment related to direct PE inputs as
described in the CY 2015 PFS final rule with comment period (79 FR
67557). Therefore, we are finalizing the PE inputs and refinements for
CPT 93350 and 93351 as proposed.
(44) Peripheral Artery Disease (PAD) Rehabilitation (CPT Code 93668)
We have issued a national coverage determination (NCD) for Medicare
[[Page 53066]]
coverage of supervised exercise therapy (SET) for the treatment of
peripheral artery disease (PAD). Information regarding the NCD can be
found on the CMS Web site at https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=287. CPT code 93668,
currently assigned PROCSTAT N (noncovered service by Medicare), will be
payable before the end of CY 2017, retroactive to the effective date of
the NCD to implement payment under the NCD.
For CY 2018, we proposed to make payment for Medicare-covered SET
for the treatment of PAD, consistent with the NCD, reported with CPT
code 93668. For CPT code 93668, we proposed to use the most recent RUC-
recommended work and direct PE inputs. We are also sought comment on
the coding structure and valuation assumptions. Since the RUC has not
reviewed CPT code 93668 since 2001, we sought comments on the direct PE
inputs assigned to the code, which appear in the direct PE input
database. We also noted that CPT code 93668 is a PE-only code and does
not include physician work.
CPT prefatory language states that CPT code 93668 may be separately
reported with appropriate E/M services, including office and/or
outpatient services (CPT codes 99201 through 99215), initial hospital
care (CPT codes 99221 through 99223), subsequent hospital care (CPT
codes 99231 through 99233), and critical care services (CPT codes 99291
through 99292). Our understanding of CPT's prefatory language is that
these E/M codes may only be billed when review or exam of the patient
is medically indicated and must conform to all existing E/M
documentation requirements. E/M visit codes should not be billed to
account for supervision of SET for the treatment of PAD by a physician
or other qualified healthcare practitioner. We sought comments on
whether to develop professional coding to reflect the supervision of
clinical staff, and on the potential overlap with CPT code 99211
(Office or other outpatient visit for the evaluation and management of
an established patient, that may not require the presence of a
physician or other qualified health care professional. Usually, the
presenting problem(s) are minimal. Typically, 5 minutes are spent
performing or supervising these services.) and any distinctions between
time spent by clinical staff for CPT code 99211 and time spent by
clinical staff for CPT code 93668.
Comment: Commenters were supportive of CMS' proposal to make CPT
code 93668 active for CY 2018 and payable before the end of CY 2017,
retroactive to the effective date of the NCD, to facilitate separate
payment for SET. The RUC responded to CMS' request for comment on the
coding structure and the valuation assumptions by stating that it
intends to work with the specialty societies through the CPT Editorial
Panel and the RUC process to evaluate both. The RUC recommended
maintaining current PE inputs until they provide recommendations for CY
2019.
Response: We will be maintaining the current PE inputs until we
receive a new recommendation from the RUC.
Comment: One commenter stated that advanced practice providers,
such as nurse practitioners, clinical nurse specialists, or physician
assistants, should be able to refer patients for SET. This commenter
noted that these practitioners are often relied up to provide referrals
and education for patients.
Response: Under the conditions of the NCD, beneficiaries must have
a face-to-face visit with the physician responsible for the overall PAD
treatment to obtain a referral for SET.
After consideration of these public comments, we are finalizing the
RUC-recommended values for CPT code 93668, as proposed.
(45) INR Monitoring (CPT Codes 93792 and 93793)
In October 2015, AMA staff assembled a list of all services with
total Medicare utilization of 10,000 or more that have increased by at
least 100 percent from 2008 through 2013, and these services were
identified on that list. The RUC recommended that HCPCS codes G0248,
G0249 and G0250, which describe related INR monitoring services, be
referred to the CPT Editorial Panel to create Category I codes to
describe these services.
For CY 2018, the CPT Editorial Panel is deleting CPT codes 99363
and 99364 and creating new CPT codes 93792 (Patient/caregiver training
for initiation of home INR monitoring under the direction of a
physician or other qualified health care professional, including face-
to-face, use and care of the INR monitor, obtaining blood sample,
instructions for reporting home INR test results, and documentation of
patient's/caregiver's ability to perform testing and report results)
and 93793 (Anticoagulant management for a patient taking warfarin, must
include review and interpretation of a new home, office, or lab
International Normalized Ratio (INR) test result, patient instructions,
dosage adjustment (as needed), and-scheduling of additional test(s)
when performed). CPT code 93792 is a technical component-only code.
With the creation of CPT codes 93792 and 93793, the RUC recommended
that CMS delete HCPCS codes G0248, G0249 and G0250.
For CPT code 93793, we proposed the RUC-recommended work RVU of
0.18. Because HCPCS codes G0248, G0249 and G0250 are used to report
related services under a Medicare National Coverage Determination, we
did not propose to delete the G-codes.
In reviewing the recommended PE inputs for these services, we
obtained updated invoices for prices for particular items. We proposed
to use the invoices to update the price of the supply ``INR test
strip'' (SJ055). We obtained publically available pricing information
from two vendors. The pricing from one vendor indicated the price for a
box of 24 of supply item SJ055 item (INR test strip) is $150.00, which
equated to a unit price of $6.25. Pricing from a second vendor
indicated the price of a box of 48 of the supply item SJ055 to be
$233.00, which equated to a unit price of $5.06. The average price of
these two unit prices is $5.66.
Therefore, we proposed to re-price SJ055 from $21.86 to $5.66 for
CPT code 93792. We sought public comments on current pricing for the
INR test strip supply.
Comment: In general, commenters were supportive of our proposal of
the RUC-recommended work RVUs.
Response: We appreciate the commenters' feedback. We continue to
welcome information from all interested parties regarding valuation of
services for consideration through our rulemaking process.
Comment: The RUC noted that it agreed with CMS' proposal to update
the price of the thirteen supplies and one equipment item listed on
Table 14: CY 2018 Proposed Rule Invoices Received for Existing Direct
PE Inputs of the CY 2018 proposed rule (82 FR 34078).
Response: We thank the RUC for its support and note that the re-
price of supply item SJ055 was included in Table 14: CY 2018 Proposed
Invoices Received for Existing Direct PE Inputs of the CY 2018 proposed
rule (82 FR 34078).
Comment: A commenter disagreed with our proposed re-pricing of
SJ055, noting that it would result in an RVU reduction of almost 50
percent for HCPCS codes G0248 and G0249, which would adversely impact
access to these services.
This commenter discussed ``home-use'' vs ``professional-use only''
INR test strips, noting that the method CMS used to re-price SJ055 was
incorrect because
[[Page 53067]]
the pricing information was based on two vendors who were selling
``professional-use only'' strips in units of 24 and 48. The commenter
provided publicly available pricing information and recommended that we
re-price the INR test strip to $20.31 per unit, inclusive of $1.85 per
unit for shipping.
Response: In reviewing the publicly available pricing information
provided by the commenter, the price for a box of 6 INR test strips was
noted at $110.79, which equated to $18.46 per test strip. We note that
the product did not make a distinction of ``home-use'' or
``professional-use only''. Furthermore, this was the same product we
used to propose to re-price the INR test strip, but in a smaller
quantity. Because we believe it is reasonable to assume that an
efficient practice would be more likely to purchase the same supply in
a larger quantity in order to take advantage of a significantly lower
unit price for that supply, we are not including this price in our
valuation of the INR test strip.
Furthermore, given that beneficiaries are generally responsible for
paying cost-sharing, the re-price of $20.31 recommended by the
commenter would increase beneficiary cost-sharing. Also, as discussed
in the CY 2017 PFS final rule (81 FR 80525), after reviewing the public
comments in response to the CY 1998 PFS proposed rule, we finalized in
Phase I significant revisions with respect to the scope of the volume
or value standard. We revised our interpretation of the ``volume or
value'' standard for purposes of section 1877 of the Act to permit,
among other things, payments based on a unit of service, provided that
the unit-based payment is fair market value and does not vary over time
(66 FR 876 through 879).
Comment: Several commenters noted that the RVUs used to support the
ongoing provision of INR Test Materials/Equipment (that is, G0249) are
based on the patient producing 4 test results and not the IDTF simply
providing 4 test strips. These commenters recommended the inclusion of
6 to 7 or more test strips for this service. One commenter noted that
in order to produce 4 test results, IDTFs must provide a sealed vial of
6 test strips and that two additional strips are used to allow patients
to re-confirm critical out of range (or aberrant) test results before
their physician alters therapy.
Response: The commenter did not provide, nor were we able to find,
documentation to support the requirement for a sealed vial of 6 test
strips.
After consideration of the comments received, we will finalize the
re-price of SJ055 as proposed, and increase the number of INR test
strips by two as recommended by commenters.
Comment: One commenter noted that the supply ``INR test strip''
(SJ055) is categorized as ``Pharmacy, Non-Rx'' but should be more
accurately categorized as ``Pharmacy, Rx''.
Response: Historically, this supply item has been categorized as
``Pharmacy, Non-Rx''. We note that the internal use of this
categorization does not have an impact on how this supply is priced
under the PFS.
After consideration of the comments received, we will finalize the
re-price of SJ055 as proposed, but will increase the number of INR test
strips by two, as recommended by commenters. We will also increase the
number of lancets and alcohol swab-pads by two each, which we believe
are typically used to furnish this service. For CPT code 93793, we are
finalizing the RUC-recommended work RVU of 0.18 for CY 2018, as
proposed.
(46) Pulmonary Diagnostic Tests (CPT Codes 94621, 94617, and 94618)
CPT code 94620 was identified as part of a screen of high
expenditure services with Medicare allowed charges of $10 million or
more that had not been recently reviewed. CPT code 94621 was added to
the family for review. The CPT Editorial Panel deleted CPT code 94620
and split it into two new codes, CPT codes 94617 and 94618, to describe
two different tests commonly performed for evaluation of dyspnea. We
proposed the RUC-recommended work RVUs of 1.42 for CPT code 94621, 0.70
for CPT code 94617, and 0.48 for CPT code 94618.
We proposed to refine the clinical labor time for the ``Provide
preservice education/obtain consent'' activity from 10 minutes to 5
minutes for CPT code 94621, which is the current time assigned for this
task. While we agree that CPT code 94621 requires additional time above
the standard for this clinical labor activity, we do not believe that
double the current time would be typical for this procedure. We also
proposed to refine the clinical labor time for the ``Prepare and
position patient/monitor patient/set up IV'' activity from 5 minutes to
3 minutes for the same code. The standard time for this activity is 2
minutes, and we proposed a value of 3 minutes to reflect 1 minute of
additional preparation time above the standard. We believed that
additional clinical labor time used for preparation would be included
under the 10 minutes assigned to the ``Prepare room, equipment,
supplies'' activity for this code.
We proposed to refine the clinical labor time for the ``Complete
diagnostic forms, lab & X-ray requisitions'' activity, consistent with
the standard clinical labor time for this activity. We also proposed to
refine the equipment times for CPT codes 94621 and 94617 to account for
1:4 patient monitoring time, and to refine the equipment times for CPT
code 94618 consistent with standards for non-highly technical
equipment.
We considered refining the clinical labor time for the ``pre
exercise ECG, VC, Min Vent. Calculation'' activity from 27 minutes to
15 minutes for CPT code 94621. We considered proposing this value of 15
minutes based on assigning 5 minutes apiece for the ECG, the MVV, and
the spirometry. We believed that each of these three components of this
clinical labor activity would typically take no longer than 5 minutes
based on a comparison to the use of these tasks in other CPT codes. We
also considered refining the clinical labor time for the ``Clinical
staff performs procedure'' activity from 55 minutes to 35 minutes for
CPT code 94617 and from 14 minutes to 12 minutes for CPT code 94621.
The RUC-recommended materials for the PE inputs state that this
clinical labor task consists of performing 5 spirometries at 9 minutes
each plus 10 minutes of exercise time for CPT code 94617; we believed
that the spirometries typically take 5 minutes each, which would reduce
this activity from 55 minutes to 35 minutes. For CPT code 94621, we
considered maintaining the current value of 12 minutes due to a lack of
justification for increasing the time to 14 minutes.
While we remained concerned about the intraservice period clinical
labor times, for CY 2018, we proposed the RUC-recommended work RVUs for
each code in this family and sought comment on whether our alternative
clinical labor times would better reflect the work and times for these
services.
Comment: The commenters supported the proposed values for all three
of the codes but disagreed with the alternative values.
Response: We continue to welcome information from all interested
parties regarding valuation of services for consideration through our
rulemaking process. We will continue to consider alternative work RVUs
as we propose the valuation of services for future notice and comment
rulemaking.
Comment: Several commenters disagreed with the proposal to refine
the clinical labor time for the ``Provide preservice education/obtain
consent'' activity from 10 minutes to 5 minutes
[[Page 53068]]
for CPT code 94621. Commenters stated that the explanation to the
patient involves a back and forth discussion that is important for
obtaining an accurate test for the patient, and this education cannot
be rushed. The commenters indicated that sufficient time for informed
consent is also important since exercising to maximal capacity does
have risks, including death, and testing may include additional
invasive procedures which require additional and adequate explanation
to the patient.
Response: We agree that there is an important need for preservice
education and that this service requires additional clinical labor time
beyond the standard. However, the standard time for this clinical labor
activity is 3 minutes, and CPT code 94621 is currently receiving
additional time beyond the standard with 5 minutes of allocated
clinical labor time. We continue to believe that increasing the
clinical labor time for preservice education above the current
valuation would not be typical for this procedure.
Comment: Several commenters disagreed with the proposal to refine
the clinical labor time for the ``Prepare and position patient/monitor
patient/set up IV'' activity from 5 minutes to 3 minutes for the same
code. Commenters stated that any breakdown in monitoring or IV access
during the test itself adversely impacted the ability to interpret the
test due to a lack of full and continuous data, and could also impact
the validity of the test if the patient exercise were interrupted for
any reason. Commenters explained that it takes more than the standard
time to set up patient with 10 ECG leads and a blood pressure cuff, fit
the patient with a face mask ensuring tight seal, and position on the
bicycle ergometer.
Response: After reviewing this additional information, we agree
with the commenters that 5 minutes would be typical to conduct the
positioning as described. We are finalizing a clinical labor time of 5
minutes for the ``Prepare and position patient/monitor patient/set up
IV'' clinical labor activity for CPT code 94621.
Comment: Several commenters disagreed with the proposal to refine
the clinical labor time for the ``Complete diagnostic forms, lab & X-
ray requisitions'' activity to 3 minutes, consistent with the standard
clinical labor time for this activity. Commenters stated that the
technician had to summarize over 40 pages of data and compile reports
for physician to interpret, including ECG and spirometries.
Response: We continue to believe that 3 minutes would be typical
for three codes, consistent with the standard clinical labor time for
this activity. We did not receive any information from the commenters
to suggest that the standard clinical labor time would not be typical
for these services.
Comment: Several commenters disagreed with the proposed refinements
to the equipment time for these three codes. Commenters stated that CMS
proposed the use of a 1:4 patient monitoring time rather than the RUC
recommended 1:1 time. Commenters explained that patients recover in the
testing room, not a separate room, while technologists are cleaning
equipment, and therefore the equipment time could not be a 1:4 ratio
because the typical procedure environment allowed only one patient in
one room.
Response: We believe that the specific refinement comment used for
the equipment time in CPT codes 94621 and 94617 (Refined equipment time
to conform to established policies for equipment with 4x monitoring
time) may have been misinterpreted by the commenters. This specific
comment was intended to convey only that the equipment times were
adjusted in accordance with our standard equipment time formulas. In
the specific context of CPT codes 94621 and 94617, this refinement
comment indicated that we did not include the clinical labor time for
``Complete diagnostic forms, lab & X-ray requisitions'' into the
equipment times for these two codes, as this clinical labor activity is
not part of our standard equipment formula and we do not believe that
equipment such as the pulse oximeter would typically be in use while
completing forms. Aside from the removal of this single clinical labor
activity's time, the proposed equipment time formula for these two
codes was the same as the RUC-recommended equipment time formula. We
were not conveying a clinical judgment about the use of 1:4 patient
monitoring time as opposed to 1:1 patient monitoring time for these
services. However, we do note that the RUC's recommendations for CPT
codes 94621 and 94617 include the clinical labor activity ``Monitor pt.
following procedure/check tubes, monitors, drains, multitasking 1:4'',
which led us to believe that 1:4 patient monitoring time was in use for
these services. If we were to adopt 1:1 patient monitoring time for
these services, we note that this would reduce the equipment times for
CPT code 94621 by 22 minutes and for CPT code 94617 by 6 minutes. After
consideration of the comments, we are finalizing the 1:4 patient
monitoring time.
After consideration of comments received, for CY 2018, we are
finalizing the work RVUs for the codes in the pulmonary diagnostic
tests family as proposed. We are finalizing the direct PE inputs for
these codes as proposed along with the refinements detailed above in
response to the comments.
(47) Percutaneous Allergy Skin Tests (CPT Code 95004)
In the CY 2016 PFS proposed rule (80 FR 41706), CPT code 95004 was
identified through the high expenditures screen as potentially
misvalued. The RUC suggested in its comments on the CY 2016 PFS
proposed rule (80 FR 41706), that CPT code 95004 should be removed from
the list of potentially misvalued codes because it has a work RVU of
0.01 and that it would serve little purpose to survey physician work
for this code. The RUC and CMS previously determined that there is
physician work involved in providing this service since the physician
must interpret the test and prepare a report. In the CY 2016 PFS final
rule with comment period (80 FR 70913), CMS reiterated an interest in
the review of work and PE for this service.
We note that our interest in stakeholder review of a particular
code should not be considered a directive for survey under the RUC
process. We intend to more clearly state our interests in the future,
so that under similar circumstances, such effort need not be undertaken
based on a mistaken impression. To reiterate, we believed that whether
or not a code should be surveyed in response to our interest in
receiving recommendations regarding the work RVUs should be at the
discretion of the RUC and the specialty societies. In many cases, we
have used recommendations developed through means other than surveys in
developing RVUs. For example, for many PFS services, the direct PE
inputs are the primary drivers of overall RVUs and Medicare payment. In
most of these cases, the recommended inputs are not derived from survey
data. In some cases, especially for resource-intensive and highly
technical services, we have expressed some concern about the lack of
survey or other broad-based data that we have relied on in developing
rates across the PFS for many years.
For CY 2018, we proposed the RUC-recommended work RVU of 0.01 for
CPT code 95004.
Regarding direct PE inputs, we proposed to refine the equipment
times for the ``exam table'' (EF023) and the ``mayo stand'' (EF015) to
79 minutes
[[Page 53069]]
each to account for clinical 1:4 patient monitoring time. We received
invoices with new pricing information for two supplies: SH101
``negative control, allergy test'' ($5.17) and SH102 ``positive
control, allergy test'' ($26.12). Using this information, we proposed a
price of $0.03 per test for supply item SH101 and a price of $0.13 per
test for supply item SH102.
Comment: In general, commenters were supportive of our proposal of
the RUC-recommended work RVUs.
Response: We will continue to consider alternative work RVUs as we
propose the valuation of services for future notice and comment
rulemaking. We appreciate the commenter's feedback.
Comment: Several commenters noted that they would expect that CMS
will phase in reductions for this service.
Response: The payment reductions for CPT code 95004 are subject to
the phase-in. We note that the CY 2018 PFS Final Rule List of Codes
Subject to Phase-in is available on the CMS Web site under the
downloads section of the CY 2018 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-;Service-Payment/PhysicianFeeSched/PFS-
Federal-Regulation-Notices.html. For a more detailed description of the
methodology for the phase-in of significant RVU changes, we refer
readers to the CY 2016 PFS final rule with comment period (80 FR
70927).
After consideration of the comments received, we are finalizing the
work RVUs and PE inputs for CPT code 95004, as proposed.
(48) Continuous Glucose Monitoring (CPT Codes 95250, 95251, and 95249)
CPT codes 95250 (Ambulatory continuous glucose monitoring of
interstitial tissue fluid via a subcutaneous sensor for a minimum of 72
hours; sensor placement, hook-up, calibration of monitor, patient
training, removal of sensor, and printout of recording) and 95251
(Ambulatory continuous glucose monitoring of interstitial tissue fluid
via a subcutaneous sensor for a minimum of 72 hours; interpretation and
report) are used to report the technical and professional component for
continuous glucose monitoring. In April 2013, CPT code 95251 was
identified through the high volume growth services screen and
subsequently this code family was reviewed at the RUC's October 2016
meeting.
For CY 2018, we proposed the RUC-recommended work RVU of 0.70 for
CPT code 95251. However, we were concerned and sought comments on
whether the 2 minutes of physician preservice time was necessary. Since
CPT code 95251 is typically billed with an E/M service on the same day,
we believed the 2 minutes of preservice time may be duplicative.
Furthermore, we sought comment on whether it would be typical for the
physician to spend 2 minutes to obtain the CGM reports for review since
we believed the report would typically be obtained by clinical staff on
behalf of the physician.
For the direct PE inputs, the RUC submitted 19 invoices to update
the price of the medical supply item ``glucose monitoring
(interstitial) sensor'' (SD114) for CPT code 95250. We proposed to use
these invoice prices for the glucose monitoring (interstitial) sensor
(SD114), with an average cost of $53.08. Therefore, we proposed to use
the average price of $53.08 for this supply item.
As part of our review of this service, we obtained publicly
available pricing information for the CGM system (EQ125). We reviewed
the information provided in a study titled, ``The cost-effectiveness of
continuous glucose monitoring in type 1 diabetes,'' (Huang, SE.,
O'Grady, M., Basu, A. et al., Diabetes Care. June 2010), which
indicated the price of CGM technology (without sensors) from 3
different vendors, reflective of full retail prices with no insurer
discounts, to be $600.00, $1119.00, and $1250.00, which equated to an
average cost of $1016.00 for the CGM system. In addition, we obtained
publicly available pricing information for two vendors. This
information indicated the price of a CGM system to be $1061.90 and
$1279.17, which equated to an average cost of $1170.54. For CY 2018, we
proposed to price supply items SD114 at $53.08 and EQ125 at $1170.54.
We sought comments on current pricing for equipment item ``continuous
glucose monitoring system'' (EQ125).
Comment: In general, commenters were supportive of our proposal of
the RUC-recommended work RVUs. Some expressed opposition to the
alternative work RVUs.
Response: We will continue to consider alternative work RVUs as we
propose the valuation of services for future notice and comment
rulemaking.
Comment: The RUC noted that the CPT Editorial Panel indicated that
the new PE-only CPT code 95249 (Ambulatory continuous glucose
monitoring of interstitial tissue fluid via a subcutaneous sensor for a
minimum of 72 hours; patient-provided equipment, sensor placement,
hook-up, calibration of monitor, patient training, and printout of
recording), along with CPT codes 95250 and 95251 (with editorial
revisions), will appear in the 2018 CPT coding manual. The RUC
requested an exemption to CMS's policy to propose values in the
proposed rule for all RUC recommendations that we receive by the
February 10th deadline each year, and asked that we include CPT code
95249 in the CY 2018 PFS final rule. The RUC recommendations for CPT
codes 95250 and 95251 were affirmed without change at the April 2017
RUC meeting. At this same meeting, the RUC developed recommendations
for the direct PE inputs for the newly approved CPT code 95249, a PE-
only code that is a part of the code family that includes CPT codes
95250 and 95251. The RUC used the direct PE inputs from CPT code 95250
to derive the PE inputs for CPT code 95249 by removing PE inputs that
were not applicable to CPT code 95249. Several other commenters also
recommended inclusion of CPT code 95249 in the CY 2018 final rule.
Response: We recognize that the CPT Editorial Panel created CPT
code 95249, which is part of the family of services described by CPT
codes 95250 and 95251, in order to accommodate the different ways in
which this service can be furnished and billed. While we continue to
believe that the process we established through rulemaking where we
propose values in the PFS proposed rule and finalize values in the PFS
final rule is suitable for the vast majority of services that we price
on the PFS, we believe there is merit to the RUC's request so that we
can ensure relativity within this code family.
Comment: The RUC noted that it agreed with CMS' proposal to update
the price of the 13 supplies and one equipment item listed on Table 14:
CY 2018 Proposed Rule Invoices Received for Existing Direct PE Inputs
of the CY 2018 proposed rule (82 FR 34078).
Response: We appreciate the commenter's feedback.
After consideration of the comments received, we are finalizing the
work RVUs and PE inputs for CPT codes 95250 and 95251, as proposed. We
are also finalizing the PE inputs for CPT code 95249 and will include
this code in the CY2018 Medicare Physician Fee Schedule.
(49) Parent, Caregiver-Focused Health Risk Assessment (CPT Codes 96160
and 96161)
In the CY 2017 PFS final rule (81 FR 80330), we discussed that in
October 2015, the CPT Editorial Panel created two new PE-only codes,
CPT code 96160 (Administration of patient focused health risk
assessment instrument (e.g., health hazard
[[Page 53070]]
appraisal) with scoring and documentation, per standardized instrument)
and CPT code 96161 (Administration of caregiver-focused health risk
assessment instrument (e.g., depression inventory) for the benefit of
the patient, with scoring and documentation, per standardized
instrument). We assigned an active payment status to both codes for CY
2017 and finalized use of the RUC recommended values for these codes.
We also assigned an add-on code status to both of these services. As
add-on codes, CPT codes 96160 and 96161 describe additional resource
components of a broader service furnished to the patient that are not
accounted for in the valuation of the base code. The RUC submitted
updated recommendations for the direct PE inputs for CPT codes 96160
and 96161 after reviewing new specialty society surveys. The RUC
recommended 7 total minutes of clinical staff time, and we proposed to
adopt this number of minutes in valuing the services. The PE worksheet
included several distinct tasks with minutes for each; however, in
keeping with the standardization of clinical labor tasks, we proposed
to designate all 7 minutes under ``administration, scoring, and
documenting results of completed standardized instrument'' rather than
dividing the minutes into the four categories as shown in the RUC
recommendations.
Comment: One commenter noted that they appreciate CMS' review of
these services and agreed with the refinement to aggregate the four
clinical activities into one direct PE input.
Response: We appreciate the comment.
After consideration of the public comment, we are finalizing the
direct PE inputs for CPT codes 96160 and 96161, as proposed.
(50) Chemotherapy Administration (CPT Codes 96401, 96402, 96409, and
96411)
In the CY 2016 PFS proposed rule, CPT codes 96401 (Chemotherapy
administration, subcutaneous or intramuscular; non-hormonal anti-
neoplastic), 96402 (Chemotherapy administration, subcutaneous or
intramuscular; hormonal anti-neoplastic), 96409 (Chemotherapy
administration; intravenous, push technique, single or initial
substance/drug), and 96411 (Chemotherapy administration; intravenous,
push technique, each additional substance/drug (List separately in
addition to code for primary procedure)) were identified through the
high expenditure services screen across specialties with Medicare
allowed charges of over $10 million.
For CY 2018, we proposed the RUC-recommended work RVUs of 0.21 for
CPT code 96401, 0.19 for CPT code 96402, 0.24 for CPT code 96409, and
0.20 for CPT code 96411.
For CPT code 96402, we proposed the RUC-recommended equipment times
with refinements for the biohazard hood (EP016) and exam table (EF023)
from 31 minutes to 34 minutes to reflect the service period time
associated with this code. We proposed the RUC-recommended direct PE
inputs for CPT codes 96401, 96409, and 96411 without refinements.
Comment: In general, commenters were supportive of our proposal of
the RUC-recommended work RVUs and RUC-recommended PE inputs for these
services. One commenter noted that maintaining the recommended
physician work RVUs will promote fair and adequate reimbursement and
protect patient access.
Response: We appreciate the commenter's feedback.
Comment: One commenter noted that there are no acuity adjustments
for chemotherapy or infusion services. The commenter further noted that
CMS could enact site-of-service neutrality for payment of these codes
in addition to adding acuity adjustment modifiers to reflect more
intensive care given to some patients.
Response: We refer readers to section II.G. of this final rule for
more information on site neutrality regarding payment rates under the
Medicare physician fee schedule for nonexcepted items and services
furnished by nonexcepted off-campus provider-based departments of a
hospital. With regard to acuity adjustments for chemotherapy or
infusion services, we will consider whether to propose such adjustments
in future notice and comment rulemaking.
Comment: Several commenters supported our proposed equipment times
for the biohazard hood and the exam table to reflect the service period
time associated with CPT code 96402. One commenter noted support for
our proposal of the RUC-recommended PE inputs for the other three
services in this code family.
Response: We appreciate the comments. We note that the PE inputs
for these services are displayed in the CY 2018 PFS final rule direct
PE input database, available on the CMS Web site under the downloads
for the CY 2018 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
Comment: Several commenters expressed concern with our proposed
reductions in payment for many drug administration codes. Commenters
stated that the payment for CPT code 96402 would be reduced by almost
12 percent and that these reductions could harm access to care,
especially in rural settings, and they urged CMS not to implement them.
Furthermore, they noted that if CMS implemented the proposed payment
reductions, that it would be essential to monitor patient access to
care.
Response: We share the concern of the commenters in maintaining
access to care for Medicare beneficiaries. We continue to carefully
consider the impact that our valuation of these services will have on
beneficiary access to care. We note that we believe that improved
payment accuracy under the PFS generally facilitates access to
reasonable and necessary physicians' services. The statute requires us
to establish payments under the PFS based on national uniform RVUs that
account for the relative resources used in furnishing a service. We
proposed the RUC-recommended PE inputs for this family of services,
which were based on the expertise of the RUC. We believe that the RUC
recommendations appropriately reflect the resource costs of furnishing
the services and thus would result in appropriate valuation of these
services.
Comment: One commenter noted the importance of ensuring that
chemotherapy treatments are funded and allowed to continue in order to
sustain life.
Response: We are appreciative of the commenter's perspective and
share the commenter's concern in maintaining access to care for
Medicare beneficiaries. We did not make any proposals and are not
finalizing any policies to limit Medicare coverage of these services.
These services will be payable under the PFS for CY 2018.
Comment: One commenter noted that it was aware that CMS is
researching how to minimize payment differentials between hospital-
based infusion centers and practice infusion centers. The commenter
also noted that the coding nomenclature used for both chemotherapy and
infusion services do not have acuity adjustments. Another commenter
noted that the RVU supervision credit is only given for practice-based
infusion centers and not when the service is provided in the facility,
where many of these complicated infusions take place. They noted that
RVU supervision of these chemotherapy and infusion services
[[Page 53071]]
should be usable by both providers and facility providers.
Response: For more information on how CMS is researching how to
minimize payment differentials between hospital-based infusion centers
and practice infusion centers, we refer readers to section II.G of this
final rule for more information on payment rates under the Medicare
physician fee schedule for nonexcepted items and services furnished by
nonexcepted off-campus provider-based departments of a hospital.
After consideration of comments received, we are finalizing the
work RVUs and PE inputs for CPT codes 96401, 96402, 96409, and 96411,
as proposed.
(51) Photochemotherapy (CPT Code 96910)
CPT code 96910 appeared on a high expenditure services screen
across specialties with Medicare allowed charges of over $10 million.
It is a PE-only code that does not have a work RVU.
We proposed to refine the clinical labor time for the ``Provide
preservice education/obtain consent'' activity from 3 minutes to 1
minute for CPT code 96910. We believed that 1 minute would be typical
for patient education, as CPT code 96910 is a repeat procedure where
there would not be a need to obtain consent again. We also proposed to
remove the 2 minutes of clinical labor for the ``Complete diagnostic
forms, lab & X-ray requisitions'' activity, as this item is considered
indirect PE under our established methodology. We proposed to create a
new supply code (SB054) for the sauna suit, and proposed to price at
$9.99 based on the submitted invoice. Finally, we also proposed to
adjust the equipment times to reflect changes in the clinical labor for
CPT code 96910.
We proposed the RUC-recommended clinical labor time of 15 minutes
for the ``Prepare and position patient/monitor patient/set up IV''
activity, the RUC-recommended clinical labor time of 16 minutes for the
``Monitor patient during procedure'' activity, and the RUC-recommended
clinical labor time of 15 minutes for the ``Clean room/equipment by
physician staff'' activity, but we sought additional information
regarding the rationale for these values. Given the lack of
explanation, we considered using the current clinical labor time of 7
minutes for the ``Prepare and position patient/monitor patient/set up
IV'' activity, the current clinical labor time of 4 minutes for the
``Monitor patient during procedure'' activity, and the current clinical
labor time of 10 minutes for the ``Clean room/equipment by physician
staff'' activity. We sought comment on whether maintaining the current
values would improve relativity.
We considered removing the ``Single Patient Discard Bag, 400 ml''
(SD236) supply and replacing it with the ``biohazard specimen transport
bag'' (SM008). We were concerned about whether the single patient
discard bag is the appropriate size for storing the sauna suit used in
this procedure, and whether use of a biohazard specimen transport bag
would be typical. We sought comments on our proposed and alternative
values for these direct PE inputs.
Comment: Several commenters supported the proposed values for CPT
code 96910 but disagreed with the alternative values.
Response: We continue to welcome information from all interested
parties regarding valuation of services for consideration through our
rulemaking process.
Comment: One commenter disagreed with the proposal to refine the
clinical labor time for the ``Provide preservice education/obtain
consent'' activity from 3 minutes to 1 minute. The commenter stated
that the preservice education needed for this procedure takes longer
due to the nature of the procedure, as the staff needs to provide very
specific instructions to insure the safety and comfort of the patients
while they are in the ultraviolet treatment unit receiving treatment.
Response: After reviewing this additional information, we agree
with the commenter that 3 minutes would be typical to conduct the
preservice education as described. Therefore, we are finalizing a
clinical labor time of 3 minutes for the ``Provide preservice
education/obtain consent'' clinical labor activity for CPT code 96910.
Comment: One commenter disagreed with the proposal to remove the 2
minutes of clinical labor time for the ``Complete diagnostic forms, lab
& X-ray requisitions'' activity. The commenter stated that the
subjective, objective, assessment, and plan notes needs to be completed
for each patient.
Response: We agree with the commenter that these diagnostic forms
need to be filled out for each patient. However, this activity is
considered indirect PE under our established methodology and is
included in the administrative costs of the service. Filling out forms
or restocking shelves are necessary tasks, but they are not
individually allocable to a service and therefore fall under the
category of indirect PE.
Comment: One commenter disagreed with the proposal to adjust the
equipment times to reflect changes in the clinical labor. The commenter
did not provide a rationale for this disagreement, other than restating
its opposition to the removal of the clinical labor time and the other
proposed refinements.
Response: Over the past decade, the increasing standardization of
clinical labor tasks has resulted in greater transparency and
consistency in the assignment of equipment minutes based on clinical
labor times. We currently utilize a series of standard formulas for
equipment time, which are calculated based on the clinical labor
activities in which the equipment would typically be in use. When the
clinical labor for a procedure is altered in response to a proposal, we
will typically alter the equipment time for that procedure as well to
reflect the changes in clinical labor time, assuming of course that the
equipment in question would typically be utilized during that clinical
labor activity. We proposed to decrease the equipment time for CPT code
96910 in accordance with the changes in the proposed clinical labor
time, and we have no reason to believe that the standard equipment time
formulas would be inapplicable for this service. We also note that as a
result of the increase in the clinical labor time for the ``Obtain
vital signs'' activity from 3 minutes to 5 minutes, the final equipment
time for everything other than the phototherapy UVB measuring device
(EQ203) is 67 minutes, the same equipment time contained in the RUC's
recommendations.
After consideration of comments received, we are finalizing the
direct PE inputs for CPT code 96910 as proposed, with the exception of
the change to the ``Provide preservice education/obtain consent''
clinical labor activity, as detailed above.
(52) Photodynamic Therapy (CPT Codes 96567, 96573, and 96574)
CPT code 96567 was identified as potentially misvalued through a
CMS screen for codes with high expenditures. This code describes a
service furnished by clinical staff and does not include physician
work. For CY 2018, the CPT Editorial Panel created two new codes, CPT
codes 96573 and 96574, to describe photodynamic therapy by external
application of light to destroy premalignant skin lesions, including
the physician work involved in furnishing the service. CPT codes 96567,
96573, and 96574 were reviewed during the RUC's January 2017 meeting.
For CY 2018, we proposed the RUC-recommended work RVUs for CPT
[[Page 53072]]
codes 96573 (a work RVU of 0.48) and 96574 (a work RVU of 1.01).
We proposed the RUC-recommended PE inputs with refinements due to
inconsistencies between the stated description of clinical activities
and the submitted spreadsheets. First, we proposed to add assist
physician clinical staff time to CPT codes 96573 (10 minutes) and 96574
(16 minutes), which is equivalent to the physician intraservice times
for these services. For both CPT codes 96573 and 96574, we proposed a
reduction from 35 minutes to 17 minutes for clinical activity in the
postservice time, consistent with the description of clinical work in
the summary of recommendations, which states that the patient receives
activation of the affected area with the BLU-U Photodynamic Therapy
Illuminator for approximately 17 minutes. For CPT codes 96573 and
96574, we proposed to refine equipment formulas for two items: Power
table (EF031) and LumaCare external light with probe set (EQ169),
consistent with standards for nonhighly technical equipment. An
explanation of the standards and formulas for equipment related to
direct PE inputs is in the CY 2014 PFS final rule with comment period
(79 FR 67557).
Comment: Several commenters, including the RUC, disagreed with our
proposal to change the RUC-recommended clinical labor times for CPT
96573 and 96574 due to inconsistencies between the stated description
of clinical activities and the submitted spreadsheets. Commenters also
noted that Table 11 in the CY 2018 PFS proposed rule did not reflect
these changes.
Response: We appreciate commenters' attention to this discrepancy.
In the proposed rule, we wrote that we proposed this change, but as
commenters pointed out, the proposed refinements were reflected in the
data presented in Table 11. We are finalizing the RUC recommended PE
clinical labor times for these two CPT codes. We are finalizing our
proposal to refine equipment formulas for EF031 and EQ169 for these two
CPT codes, in accordance with formula standards.
We identified several vendors with publically available prices for
supply item LMX 4 percent cream (SH092) for significantly less than the
existing $1.60 per gram. Based on our research of vendors, we proposed
to set the price of supply item SH092 to $0.78 per gram. Other CPT
codes affected by the proposed change in the price of supply item LMX 4
percent cream (SH092) would be: CPT code 46607 (Anoscopy; with high-
resolution magnification (HRA) (e.g., colposcope, operating microscope)
and chemical agent enhancement, with biopsy, single or multiple), CPT
code 17000 (Destruction (e.g., laser surgery, electrosurgery,
cryosurgery, chemosurgery, surgical curettement), premalignant lesions
(e.g., actinic keratoses); first lesion), CPT code 17003 (Destruction
(e.g., laser surgery, electrosurgery, cryosurgery, chemosurgery,
surgical curettement), premalignant lesions (e.g., actinic keratoses);
second through 14 lesions, each (List separately in addition to code
for first lesion)), and CPT code 17004 (Destruction (e.g., laser
surgery, electrosurgery, cryosurgery, chemosurgery, surgical
curettement), premalignant lesions (e.g., actinic keratoses), 15 or
more lesions)).
In addition, the RUC forwarded an invoice for a new supply item,
safety goggles, at $6.00 and requested three goggles each for CPT codes
96573 and 96574. Because we did not have a basis for distinguishing the
requested new goggles from the existing UV-blocking goggles, we
considered this invoice to be an additional price point for SJ027
rather than an entirely new item. We proposed a price of $4.10 for
supply item SJ027 (the average of the two prices for this supply item
($2.30 + $6.00)/2 = $4.10)). Other CPT codes affected by the proposed
change in the price of supply item UV-blocking goggles (SJ027) are: CPT
code 36522 (Photopheresis, extracorporeal), CPT code 96910
(Photochemotherapy; tar and ultraviolet B (Goeckerman treatment) or
petrolatum and ultraviolet B), CPT code 96912 (Photochemotherapy;
psoralens and ultraviolet A (PUVA)), and CPT code 96913
(Photochemotherapy (Goeckerman and/or PUVA) for severe photoresponsive
dermatoses requiring at least 4-8 hours of care under direct
supervision of the physician (includes application of medication and
dressings)), CPT code 96920 (Laser treatment for inflammatory skin
disease (psoriasis); total area less than 250 sq cm), CPT code 96921
(Laser treatment for inflammatory skin disease (psoriasis); 250 sq cm
to 500 sq cm), and CPT code 96922 (Laser treatment for inflammatory
skin disease (psoriasis); over 500 sq cm). We sought comments on our
proposed PE refinements, including our proposed supply item prices.
Comment: Commenters generally supported our proposed work RVUs for
CPT codes 96573 and 96574. Two commenters disagreed with our proposal
to accept the RUC's recommended PE inputs for the existing CPT code
96567. They stated that the staff and equipment times for CPT codes
96567 should mirror the times in CPT code 96573, with the addition of
10 minutes for staff to apply the photosensitizing agent. As currently
proposed, the commenters noted that staff times for CPT code 96567 are
inadequate to perform the service.
Response: Based on support from commenters on our proposed work
RVUs for CPT codes 96573 and 96574, we are finalizing those values as
proposed. We thank commenters for their comments regarding clinical
labor inputs for CPT code 96567. The RUC provides recommendations
regarding clinical labor that are developed through a collaborative
process with specialty societies. The RUC did not, in its comment
letter, modify recommendations for this CPT code. The RUC has a process
for identifying potentially missing clinical labor time, and we
encourage commenters to work in concert with the RUC to resolve those
concerns.
Comment: One commenter questioned whether the CPT Editorial Panel
should have used the same code number as an existing service, rather
than a new one, to describe the revised service for CPT code 96567.
Response: In certain circumstances, we may find it necessary to
deviate from the CPT Editorial Panel's decisions. However, we note that
CMS does not direct the CPT Editorial Panel and we encourage the
commenter to follow the panel's established process for reviewing CPT
codes and descriptors.
Comment: A few commenters questioned our proposal to refine
equipment times to confirm to standard formulas. In particular, they
maintained that the equipment time for the power table should not be
refined because the patient has to stay on the table during the
illumination period and the room is not available for other patients'
use.
Response: We agree that the power table may be required throughout
the illumination period, and we would consider the recommendation if
there were additional information explaining why equipment time for the
power table included the entire service time plus 3 additional hours.
However, the total time for the power table formula of 230 minutes and
232 minutes for CPT codes 96573 and 96574, respectively, was not
consistent with the narrative accompanying the recommendation. In the
narrative for both CPT codes, illumination of the affected area is
approximately 17 minutes with no specific amount of time for incubation
provided. In the absence of additional information explaining why the
times are needed, we are finalizing our
[[Page 53073]]
proposed refinement for this and two other equipment items.
Comment: We received several comments about our proposal to reduce
the price for supply item LMX 4 percent cream (SH092) from $1.60 to
$0.78. We also received comments about our proposal to blend the prices
of two types of goggles, SJ027 and SD326.
Response: We discuss these supply items and prices in detail in
section II.B of this final rule.
(53) Physical Medicine and Rehabilitation (PM&R) (CPT Codes 97012,
97016, 97018, 97022, 97032, 97033, 97034, 97035, 97110, 97112, 97113,
97116, 97140, 97530, 97533, 97535, 97537, 97542, and HCPCS Code G0283)
In our CY 2015 PFS final rule with comment period (79 FR 67576) and
CY 2016 PFS final rule with comment period (80 FR 70917), we identified
a total of ten codes through the high expenditure by specialty screen
for services primarily furnished by physical and occupational
therapists: CPT codes 97032, 97035, 97110, 97112, 97113, 97116, 97140,
97530, 97535, and HCPCS code G0283. An additional nine codes in this
PM&R family were identified for review by the physical therapy (PT) and
occupational therapy (OT) specialty societies: CPT codes 97012, 97016,
97018, 97022, 97033, 97034, 97533, 97537, and 97542. Many of these code
values had not been reviewed since they were established in 1994, 1995
or 1998.
After review during its January 2017 meeting, the HCPAC submitted
recommendations to CMS for all 19 codes. While the HCPAC included
recommendations for CPT code 97014, we note that this is a code we have
not recognized for PFS payment since 2002 when we implemented our wound
care electrical stimulation policies. For payment under the PFS,
instead of CPT code 97014, we recognize HCPCS code G0281 for wound care
electrical stimulation and HCPCS code G0283 for all other electrical
stimulation scenarios, when covered. For CY 2018, we proposed the HCPAC
recommendations for CPT code 97014, HCPCS code G0283, and HCPCS code
G0281.
CMS considers all 19 codes as ``always therapy'' which means they
are always considered to be furnished under a physical therapy (PT),
occupational therapy (OT), or speech-language pathology (SLP) plan of
care regardless of who furnishes them and the payment amounts are
counted towards the appropriate statutory therapy cap--either the
therapy cap for PT and SLP services combined, or the single therapy cap
for OT services. These ``always therapy'' codes are also subject to the
therapy MPPR.
For CY 2018, we proposed the HCPAC's recommended work RVUs for CPT
codes 97012, 97016, 97018, 97022, 97032, 97033, 97034, 97035, 97110,
97112, 97113, 97116, 97140, 97530, 97533, 97535, 97537, 97542, and
G0283 (97014).
For supervised modality services reported with CPT codes 97012,
97016, 97018, and 97022, and HCPCS code G0283 (97014), we considered
maintaining the current values for these codes rather than the HCPAC
recommendations. We note that the work times recommended by the HCPAC
reflect use of the survey data even though the HCPAC explained in its
recommendations that the survey results were not deemed credible
because of a lack of evidence to support higher work RVUs of each
survey's 25th percentile or median values. We note total time decreases
among these codes ranging from 1 to 8 minutes.
While we proposed the HCPAC-recommended work RVUs and work times
for each code in this family, we sought comments on whether maintaining
the current times, given the HCPAC's lack of confidence in the survey
data, would better reflect the work times for these services.
We proposed to maintain the existing CY 2017 PE inputs for all 19
codes. We noted that section 1848(b)(7) of the Act requires a 50
percent therapy MPPR instead of the 25 percent therapy MPPR established
during CY 2011 PFS rulemaking. One of the primary rationales for the
MPPR policy developed through the rulemaking process was that the
direct PE inputs for these services did not fully recognize the
redundant inputs when these services were furnished together, or in
multiple units. After reviewing the recommended direct PE inputs, it
was evident that they were developed based on an acknowledgement of the
efficiencies of services typically furnished together as well as codes
billed in multiple units. Given this assessment, we believed that were
we to use the recommended inputs to develop the PE RVUs, the 50 percent
MPPR on the PE for these services, as required by current law, would
functionally duplicate the payment adjustments to account for
efficiencies that had already been addressed through code-level
valuation. Therefore, for CY 2018, we proposed to retain the existing
CY 2017 PE inputs for these services and sought comments on whether
there is an alternative approach that would avoid duplicative downward
payment adjustments while still allowing for the direct PE inputs to be
updated to better reflect current practice.
We noted that we believed that the always therapy codes subject to
the therapy MPPR on PE are unique from other therapeutic and diagnostic
procedure codes paid under the PFS and subject to MPPRs. For example,
unlike most surgical services, these ``always therapy'' codes are
typically billed either with other therapy codes or in multiple units,
or both. Generally, MPPRs are used when codes are often, but not
typically, furnished with other particular codes. When full sets of
related codes are almost all typically billed with other codes, or
billed in multiple units, coding and valuation have changed to reflect
these practices. For example, new codes have been introduced to
describe combined services or some related services are described by
add-on codes. In other cases, the MPPR is considered in the valuation
for individual services.
The following is a summary of public comments received on our
proposal to accept the HCPAC-recommended work RVUs for all 19 PM&R
codes and the request for comment for the supervised modality codes--
CPT codes 97012, 97016, 97018, and 97022, and HCPCS code G0283
(97014)--to alternatively not accept the work times:
Comment: We received many comments all of which were in support of
our proposal to accept the HCPAC-recommended work RVUs for the 19 PM&R
codes that includes an increase in work RVUs for six of the codes. The
majority of commenters disagreed with the alternative we considered to
retain the current work times associated with the five supervised
modality services, while one commenter agreed. The HCPAC and other
commenters disagreed and asked us to maintain the proposed
recommendations in this final rule because they noted that the survey's
25th percentile time for each of these codes more accurately reflects
the time necessary to perform the service and takes into account
efficiencies based on the typical number of services reported per
session. One commenter asked us to keep the current time values for the
supervised modality services reported with CPT codes 97012, 97016,
97018, and 97022, and HCPCS code G0283 (97014) and not accept the
HCPAC's proposed time values and offered several clinical scenarios for
some of the supervised modality services they believe demonstrate the
need for maintaining the current time values for these services.
Response: We appreciate the many commenters who supported our
[[Page 53074]]
proposal to accept the work RVU recommendations we received from the
HCPAC for the 19 PM&R codes. While we appreciate the various comments
we received on our alternative consideration to retain the times
associated with the work RVUs for the supervised modality codes, we are
finalizing our proposal to accept the work RVUs, including the times,
for all 19 PM&R codes.
The following is a summary of the public comments received as to
whether there is an alternative approach to our proposal to retain the
CY 2017 direct PE inputs for always therapy codes that would avoid
duplicative downward payment adjustments while still allowing for the
direct PE inputs to be updated to better reflect current practice and
our responses:
Comment: Many commenters agreed with our proposal to maintain the
existing 2017 PE inputs for all 19 PM&R codes. A number of these
commenters noted the importance of the PE values that reflect the costs
of maintaining a therapy practice (such as renting office space, buying
supplies and equipment, and staff salary/benefits). Some of these
commenters thanked CMS for recognizing that if the recommended inputs
to develop the PE RVUs were adopted, the 50 percent MPPR on the PE for
these services would duplicate the payment adjustments to account for
efficiencies that had already been addressed through the code-level
valuation process.
Several other commenters, including the HCPAC, urged us to
implement the recommended direct PE inputs. In its comment, the HCPAC
assured CMS that the RUC PE Subcommittee understood the 50 percent MPPR
and took it into account, in addition to the efficiencies of services
billed together, when reviewing the direct PE inputs for these
services. The HCPAC noted in its comment letter that the PE inputs were
reviewed with the understanding that as a result of the MPPR, a 50
percent reduction is in place for the second and subsequent reporting
of a physical medicine and rehabilitation service on the same date of
service. The HCPAC comment letter clarified that the PE Subcommittee's
recommendations apply to the 22 codes that are subject to the therapy
MPPR--the 19 codes in this PM&R section and the three codes for
orthotic and prosthetic management services (discussed in the below
section).
Response: We are persuaded by the HCPAC's reassurance that the PE
Subcommittee took the 50 percent MPPR into consideration during its
deliberative process and that the forwarded recommendations reflect the
therapy MPPR policy, in addition to the efficiencies of services billed
together. Therefore, we will not finalize our proposal to maintain the
existing direct PE inputs for therapy codes; instead, we will accept
the HCPAC recommendations for the direct PE inputs for the 19 PM&R
codes in this section and the three codes discussed in a subsequent
section for services related to orthotics and prosthetics management
and/or training.
After consideration of comments received, we are finalizing the
HCPAC-recommended work RVUs, including the times, for all 19 PM&R codes
as proposed. We are also finalizing to accept the HCPAC recommendations
for the direct PE inputs for all 19 codes.
(54) Cognitive Function Intervention (CPT Code 97127)
We received HCPAC recommendations for new CPT code 97127 that
describes services currently reported under CPT code 97532 (Development
of cognitive skills to improve attention, memory, problem solving
(includes compensatory training), direct (one-on-one) patient contact,
each 15 minutes). CPT code 97532 is scheduled to be deleted for CY 2018
and replaced by CPT code 97127.
The existing code is reported per 15 minutes and the new code is
reported once. Under current coding, Medicare utilization for these
services is heterogeneous and indicates that practitioners of different
disciplines incur significantly different resource costs (especially in
time) when furnishing these services to Medicare beneficiaries. As
described by both the existing and new code, the service might be
appropriately furnished both by therapists under the outpatient therapy
(OPT) services benefit (includes physical therapy (PT), occupational
therapy (OT) or speech-language pathology (SLP)); and outside the
therapy benefit by physicians, certain NPPs, and psychologists. As an
OPT service, it can (1) be billed by physicians, certain NPPs, or
private practice therapists including physical therapists (PT-PPs),
occupational therapists (OT-PPs) and speech-language pathologists (SLP-
PPs) in private practice, or (2) be billed by institutional providers
(for example, skilled nursing facilities, rehabilitation agencies,
outpatient hospitals, etc.) when furnished by therapists working for
the institutional providers.
According to the HCPAC, professional claims data indicate that CPT
code 97532 was most often billed in 4 units. The HCPAC recommended a
work RVU of 1.50 for CPT code 97127, which is only 3.4 times greater
than the work RVU for the predecessor code (0.44). Assuming
professional billing patterns remain the same, the recommended coding
and valuation could result in a significant reduction in overall
Medicare payment under the PFS.
However, our analysis of the claims data indicates that the number
of units typically reported for the current code suggests a significant
difference in the amount of time spent with the patient, depending on
which discipline (and implicitly under which benefit) bills Medicare
for services described by this single code.
Based on our review of claims data by specialty, SLP-PPs, OT-PPs
and PT-PPs furnishing the same services under the OPT benefit would
receive overall payment increases due simply to the change in coding
because they typically bill for fewer than 4 units, while overall
payment for clinical psychologists furnishing therapeutic interventions
for cognitive function would decrease because they typically bill in
units of four or more.
We sought additional information regarding the potential impact of
this coding and payment change prior to proposing its use under the
PFS. For CY 2018, we proposed to maintain the current coding and
valuation for these cognitive function services. If the CPT Editorial
Panel deletes the existing CPT code for CY 2018, we would effectuate
this proposal through use of a new a HCPCS code G-code, G0515, which
would maintain the descriptor and values from existing CPT code 97532.
Under this proposal, new CPT code 97127 would be given a procedure
status of ``I'' (Invalid for Medicare).
We also noted that this change in coding and payment could have
significant impact for payment to Medicare institutions for OPT
services. Under section 1834(k) of the Act, when reported by Medicare
institutional providers, OPT services are paid at PFS non-facility
payment rates. Institutional claims data for CPT code 97532 when
furnished by the three therapist disciplines show a much higher
utilization overall than that for professional claims, but
significantly fewer 15 minute units reported. This suggests that
outpatient therapy professionals generally spend significantly less
time with patients in the institutional setting. Use of the new CPT
code could, therefore, result in significant additional expenditure to
the Medicare program, as well as other payers, including Medicaid
programs, based on the change in coding alone.
[[Page 53075]]
The following is a summary of the public comments received on
additional information regarding the potential impact of this coding
and payment change prior to its use under the PFS and our responses:
Comment: The HCPAC and other commenters--after considering CMS
concerns and an independent review and analysis conducted by the
speech-language pathology specialty of Medicare Part B facility-based
claims (using the Medicare 5% Limited Data Set (LDS)) that confirmed
the same variable billing patterns and higher utilization of CPT code
97532--generally agreed with our proposal to create HCPCS code G0515
instead of recognizing CPT code 97127 in the short term and encouraged
us to work with stakeholders, including the AMA, on a more permanent
coding solution. These same commenters had expressed concern that CMS
did not use the data in the same way as the HCPAC and RUC to determine
the typical units billed, and that moving forward, they would be
interested to work with CMS to identify exceptional procedure codes
such as this one where the more commonly used database may be
misleading.
Response: We agree that the untimed CPT code 97127 designed to
replace the 15-minute timed CPT code 97532 represents an
``exceptional'' procedure code, primarily because it would be covered
and paid by Medicare under two separate benefits--one for medical
services and the other for OPT services. It is this uniqueness that
prompted us to examine the differing billing patterns of the various
practitioners furnishing these cognitive therapy services as well as
the overall utilization in all the settings it is reported. Because CPT
code 97127 would have been reported by institutional providers of OPT
services and typical units in a same-day billing file is not available,
our review required us to look at the average units reported by each
therapy discipline. We appreciate the work of the SLP and psychology
specialties in completing the HCPAC survey process for CPT code 97127,
and we thank the HCPAC and the specialty societies for recognizing our
necessity to develop HCPCS code G0515 to report these cognitive therapy
services.
Comment: One commenter expressed concern that our proposal to
create HCPCS code G0515 instead of adopting CPT code 97127 would result
in confusion for providers that would have two different codes to
report for cognitive therapy services: One for Medicare and another for
private payers. The commenter requested that we use CPT code 97127,
perhaps with modifiers to account for billing pattern differences,
unless CMS commits to extensive outreach services to the provider
community.
Response: If we were to adopt the new coding and higher payment for
CPT code 97127, instead of creating HCPCS code G0515 to maintain
current coding and valuation for these services as we proposed, we
acknowledge that the institutional providers of OPT services such as
those represented by this commenter would benefit the most from the
untimed nature of CPT code 97127, assuming current billing patterns and
resource use, since therapists in these settings typically furnish
these services in fewer units. We note that private payers have the
option to adopt our G-codes for reporting purposes. In addition, the
coding we proposed for HCPCS code G0515 is identical to that which
Medicare providers have used in the past for these cognitive therapy
services. As with all new therapy codes, we will address changes to the
2018 therapy code list made in this CY 2018 PFS final rule in an
upcoming Change Request (CR) for the 2018 Annual Update to the Therapy
Code List, CR 10303, which will be available on the 2017 Transmittals
Web page at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017-Transmittals.html.
Comment: The HCPAC and other commenters pointed out that the
description of HCPCS code GXXX1 listed in Table 10: Proposed CY 2018
Work RVUs for New, Revised and Potentially Misvalued Codes of the
proposed rule, (82 FR 34021) does not reflect CMS' intent to maintain
the descriptor for CPT code 97532.
Response: We thank the commenters for notifying us about the
incorrect descriptor for GXXX1 that we inadvertently included in Table
10 of the CY 2018 PFS proposed rule (82 FR 34021). The correct
descriptor for GXXX1/G0515 in that table should have been the same as
that for the prior CPT code 97532 that we defined and included in our
discussion as: Development of cognitive skills to improve attention,
memory, problem solving (includes compensatory training), direct (one-
on-one) patient contact, each 15 minutes.
Comment: The HCPAC and other commenters expressed concern about
CMS' refinement of PE inputs for CPT code 97127, contending that the
agency lacked a rationale for the refinements shown in Table 11--CY
2018 Proposed Codes with Direct PE Input Recommendations with
Refinements. These commenters encouraged CMS to either use the existing
PE inputs in CPT code 97532 for HCPCS code G0515 or more closely mirror
the PE refinements that were forwarded by the HCPAC for CPT code 97127
to those for CPT code 97532. The commenters noted that any changes that
result in significant deviations from current PE inputs should not be
implemented absent another review of cognitive therapy services through
the HCPAC valuation process.
Response: We thank the commenters for informing us that Table 11
contained PE input refinements for CPT code 97127. Their inclusion in
Table 11 was inadvertent given that we proposed to retain the same
valuation of CPT code 97532 for HCPCS code G0515 and not to recognize
CPT code 97127 for Medicare purposes.
Comment: One commenter asked us to provide greater insight as to
what we believe would comprise an effective permanent coding solution
that permits sufficient coverage of and fair payment for these
cognitive therapy services when furnished to outpatients in both the
professional office and facility-based settings.
Response: CMS' typical role is to review the codes forwarded to us
from the RUC and HCPAC and to agree or disagree with those valuations.
Through the review and analysis necessary for valuation purposes, we
have at times found it necessary due to Medicare programmatic concerns
to create our own G-code instead of recognizing the code sent to us, as
we did in the case of the untimed code, CPT code 97127. This code,
which represents services that are utilized and reported under two
separate benefits--medical services and outpatient therapy services--
the latter of which can be billed by facility-based providers on
institutional claims when furnished by qualified therapists, or on
professional claims by therapists in private practice, physicians, or
certain NPPs (NPs, PAs, CNSs)--presents an unusual coding challenge.
Other than what has been already discussed in this rulemaking process,
we do not believe we are in a position to provide additional insight to
a permanent code that the HCPAC has not yet forwarded to us.
After consideration of the public comments, we are finalizing our
proposal to create HCPCS code G0515 to mirror the coding and valuation
of existing CPT code 97532, instead of adopting CPT code 97127. We will
assign CPT code 97127 a status indicator of ``I'' to indicate that it
is ``Invalid'' for Medicare policy and payment purposes.
We have designated HCPCS code G0515 a as ``sometimes therapy''
code,
[[Page 53076]]
which means that an appropriate therapy modifier--GN, GO or GP, to
reflect that it is under an SLP, OT, or PT plan of care--is always
required when this service is furnished by therapists; and, when it is
furnished by or incident to physicians and NPP when the services are
integral to an SLP, OT, or PT plan of care. Accordingly, HCPCS code
G0515 is sometimes appropriately reported by physicians, NPPs, and
psychologists without a therapy modifier when it is appropriately
furnished outside an SLP, OT, or PT plan of care. When furnished by
psychologists, the services of HCPCS code G0515 are never considered
therapy services and may not be reported with a GN, GO, or GP therapy
modifier.
(55) Management and/or Training: Orthotics and Prosthetics (CPT Codes
97760, 97761, and 977X1)
For CY 2018, the CPT Editorial Panel revised the set of codes that
comprise the CPT manual's PM&R subsection for orthotic management and
prosthetic management at its September 2016 meeting. According to the
CPT Editorial Panel, these revisions were made at the request of the
specialty societies representing physical and occupational therapists
to differentiate between the initial and subsequent encounters and to
describe the ongoing management and/or training that is involved in
subsequent encounters. These changes include:
Revising the code descriptors by adding the term ``initial
encounter'' to CPT code 97760 (Orthotic(s) management and training
(including assessment and fitting when not otherwise reported), upper
extremity(ies), lower extremity(ies) and/or trunk, initial orthotic(s)
encounter, each 15 minutes), and CPT code 97761 (Prosthetic(s)
training, upper and/or lower extremity(ies), initial prosthetic(s)
encounter, each 15 minutes);
Creating a new CPT code 977X1 (Orthotic(s)/prosthetic(s)
management and/or training, upper extremity(ies), lower extremity(ies),
and/or trunk, subsequent orthotic(s)/prosthetic(s) encounter, each 15
minutes); and
Deleting CPT code 97762 (checkout for orthotic/prosthetic
use, established patient, each 15 minutes).
Intended for the management and/or training of patients with
orthotics and/or prosthetics, CPT codes 97760 and 97761 were previously
used to report both the initial and subsequent encounters, that, when
furnished under the Medicare outpatient therapy services benefit,
included services occurring during the same PT or OT episode of care.
CPT code 97762 was used to separately report the assessment and fitting
(including any adjustments) of an orthotic or prosthetic for an
established patient when these services were not bundled into another
code or service. For CY 2018, CPT codes 97760 and 97761 are intended to
be reported only for the initial encounter, and CPT code 977X1 is
intended to be reported for all other orthotic and/or prosthetic
services for an established patient that occur on a ``subsequent
encounter'' or a different date of service from that of the initial
encounter service.
The HCPAC submitted work and PE recommendations for CPT codes
97760, 97761, and 977X1 from their January 2017 meeting. For CY 2018,
we proposed the HCPAC-recommended work RVU of 0.50 for CPT code 97760,
a work RVU of 0.50 for CPT code 97761, and a work RVU of 0.48 for CPT
code 977X1. We noted that for budget neutrality purposes, the HCPAC
recommendations also included utilization crosswalks for each of the
three codes that were each assigned a one-to-one crosswalk to the
utilization of the prior codes: All the prior services of CPT codes
97760 and 97761 were each crosswalked to the same newly revised codes;
and, all the utilization from CPT code 97762 was crosswalked to the new
CPT code 977X1.
For CPT code 977X1, we considered a work RVU of 0.33, crosswalking
to CPT code 92508 (Speech/hearing therapy), which has a similar total
therapist time (22 minutes). We were concerned and sought comments on
the HCPAC one-to-one utilization crosswalk recommendations for all
three codes in this family since the utilization assumptions are
potentially flawed when viewed in the context of the new CPT code
descriptors. For instance, for CPT code 977X1, the new descriptor
indicates that the services inherent to CPT code 97762 (over 14,000 in
2015), as well as the new services for subsequent encounters previously
reported via CPT codes 97760 and 97761 will also be encompassed,
although it is difficult to estimate the number of additional services
the latter represents. We were concerned that the HCPAC's valuation is
inconsistent with the submitted information regarding how services will
be reported under the new coding. We sought comments on our proposed
and alternative values for CPT code 977X1. We were also interested in
receiving comments from stakeholders and clinicians with expertise in
furnishing these orthotic management and/or prosthetics training
services about the utilization and types of services that would be
furnished under the new CPT coding structure, particularly those of the
newly created CPT code 977X1 and how these services differ from the
services reported with the predecessor CPT code 97762.
We proposed to maintain the current PE inputs for CPT codes 97760,
97761, and 977X1, as we discussed in our proposals for the PM&R codes
discussed above; the same therapy MPPR applies. We proposed the current
direct PE inputs for CPT code 97762 and for new CPT code 977X1, though
we sought comment as to whether or not a different crosswalk or other
adjustment would be appropriate given the change in code descriptor.
The following is a summary of the public comments received as to
whether or not a different crosswalk or other adjustment would be
appropriate for CPT code 97763 given the change in code descriptor and
our responses:
Comment: Many commenters supported of our proposal to adopt the
HCPAC recommendations for revised work RVUs for CPT codes 97760 and
97761, and the proposed work RVU of newly created CPT code 977X1/97763.
A few commenters also expressed support for the revised CPT descriptors
of codes 97760 and 97761 to include the term ``initial encounter'',
which they believe will eliminate billing confusion; and, also that the
addition of the term ``subsequent encounter'' to the descriptor of CPT
code 97763, because, the commenters stated it clarifies when this code
is used--that, for the same patient, the provider would only report CPT
code 97763 on the second or other subsequent visit after previously
reporting an initial encounter for orthotic and/or prosthetic training
and management using either CPT code 97760 or 97761. Other commenters
informed us that they support the revised descriptors because they
better align with the descriptions used within the ICD-10 system. One
commenter noted that the new descriptors designation of subsequent or
initial services will contribute confusion to the coding process for
these services.
Response: We appreciate the support of the many commenters for our
proposal to accept the work RVU values for these orthotic and/or
prosthetic management and training services.
Comment: In response to our alternative work valuation of 0.33 RVUs
for CPT code 97763, several commenters disagreed, stating that the
suggested crosswalk to CPT code 92508 is inappropriate, that the work
involved in delivering the orthotic/prosthetic subsequent encounter
service is very similar to that furnished in the initial encounter, as
substantiated through the
[[Page 53077]]
HCPAC survey process. One commenter that does not support the 0.33 work
RVU, told us they agree with our crosswalk of CPT code 92508 for
purposes of therapist time (17 minutes), given that we were limited for
comparable crosswalks since the 97000 series of codes was under review.
Another commenter noted that our alternative value was too low and that
we should adopt the higher value based on their belief that many
``orthotics and prosthetics require increasingly complex and critical
subsequent encounter adjustments based on changes in the status of a
patient. These services often require a great deal of time and
expertise on the part of the therapist.'' In addition, the commenter
noted that some orthotic devices are dynamic in nature and need regular
adjustments to ensure that the fit is correct and that orthotics and
prosthetics management and training technology has evolved since the
last valuation of these codes, meaning more specialized expertise is
needed by a therapist.
Response: We thank the commenters for their input. We continue to
believe that the proposed value most accurately captures the work
involved in this service. As a result, we are finalizing our proposed
value for CY 2018.
Comment. One commenter supported ``CMS' proposal to eliminate code
97762'' but did not support the adoption of CPT code 97763 in its place
because in their view it eliminates the evaluation component of CPT
code 97760 that was previously used to report subsequent encounters for
orthotic management services. This commenter believes that the new CPT
codes descriptors complicate coding through the unnecessary designation
of subsequent or initial services. This commenter also noted this to
mean that all other encounters are subsequent encounters to this
initial fabrication--which they believe is typically billed using a
HCPCS L-code; that the new CPT code 97763 is redundant because it is
used at a subsequent encounter from the one during which the orthosis
was fabricated, and that CPT code 97760 is the only code needed to bill
correctly for both the evaluation of fit and use, subsequent
modifications and additional training or repairs revealed during
reassessment of the orthosis. Regardless of the specific encounter
during which these orthotic management services are billed, the
commenter noted that the level of work is the same--supporting the
increased work RVUs of code 97760.
Response: We thank the commenter for the information provided on
their coding concerns and their support for the work RVU of CPT code
97760. We note that while CMS proposes and finalizes the valuation of
these services, it is the CPT Editorial Panel that revises CPT
descriptors as well as adds and deletes CPT codes.
Comment. Several commenters expressed concern that the HCPAC one-
to-one utilization crosswalk recommendations for all three codes in
this family are potentially flawed when viewed in the context of the
new CPT code descriptors. One commenter stated that they anticipate
there will be a redistribution in coding between CPT codes 97760 and
97761 to 977X1/97763 based on the assumption that the majority of
patients have more than 1 billing session for an orthosis or
prosthesis; therefore, the commenter estimated some volume of services
previously billed under CPT codes 97760 and 97761 will be billed under
CPT code 977X1. Another commenter noted the code descriptor revisions,
particularly the addition of ``initial encounter'' to CPT code 97760,
could be interpreted to include that encounter in which the therapist
billed for the fabrication of the orthotic using an HCPCS L-code, and
could result in a shift to CPT code 97763.
Response: We appreciate the feedback that these commenters provided
on the utilization crosswalk recommendations from the HCPAC, and note
that these concerns echo some of the concerns that we raised in the CY
2018 PFS proposed rule. After consideration of the public comments, we
are finalizing our proposal to accept the HCPAC recommended work RVUs
for CPT codes 97760, 97761, and 97763. Because these codes are subject
to the same MPPR policy as the 19 PM&R codes discussed in the above
section, we are not finalizing our proposal to retain the existing PE
inputs for these three codes. Instead, we are not finalizing our
proposal to retain the existing PE inputs for these three codes
because, as we discussed in an above section on PM&R codes, we were
persuaded by the HCPAC that the PE Subcommittee took into account the
50 percent MPPR policy when developing the PE inputs for these codes.
We also note that these codes are designated as ``always therapy,''
meaning that they always represent therapy services regardless of who
furnishes them; and that a GO or GP therapy modifier is always required
to indicate that the services are furnished under an OT or PT plan of
care, respectively. As ``always therapy,'' these codes are subject to
the therapy MPPR and the statutory therapy caps.
(56) Assessment of and Care Planning for Patients With Cognitive
Impairment (CPT Code 99483)
For CY 2017, CMS began making separate payment for HCPCS code G0505
(Assessment and care planning for patients with cognitive impairment)
as an interim means of facilitating payment for a CPT code that was
forthcoming for CY 2018, eventual CPT code 99483. As part of public
comment on the CY 2017 PFS proposed rule, the RUC submitted recommended
values for this code, which we adopted in the CY 2017 PFS final rule.
For CY 2018, CMS is adopting CPT code 99483, and deleting the interim
HCPCS code G0505. As is our longstanding practice, when we propose to
accept the RUC-recommended values for a code and did not have any
significant concerns, we did not write about this proposal in the
preamble to the CY 2018 PFS proposed rule.
Comment: Several commenters supported the adoption of CPT code
99483. Commenters stated that by making separate payment for this code,
we were helping patients with dementia gain access to valuable medical
care. One commenter also included questions that it had gathered from
practitioners about billing HCPCS code G0505. We did not receive any
comments that opposed adoption of CPT code 99483.
Response: We thank commenters for their support, and will consider
the practitioners' questions for forthcoming guidance, as appropriate.
Comment: A few commenters noted that there were slight variations
in scope of service elements between the HCPCS code G0505 and CPT code
99483.
Response: We believe that despite the differences, the policies of
CPT code 99483 conform to those of the HCPCS G-code and intend to
monitor this service and seek input from stakeholders as to whether we
should issue additional regulatory or sub-regulatory guidance.
For CY 2018, CMS is deleting the interim HCPCS code G0505 and
replacing it with CPT code 99483. After consideration of these
comments, we are finalizing the new descriptor for CPT code 99483, as
proposed. We note that we previously adopted the RUC-recommended values
for this service in the CY 2017 PFS final rule and will continue to use
the RUC-recommended values with our adoption of CPT code 99483.
(57) Psychiatric Collaborative Care Management Services (CPT Codes
99492, 99493, 99494, and 99484).
In the CY 2017 PFS final rule (81 FR 80230), we established
separate
[[Page 53078]]
payment for three services (HCPCS codes G0502, G0503, and G0504) under
the psychiatric collaborative care model that paralleled CPT codes that
were being created to report these services as well as a G-code for
general behavioral health integration (BHI) services (HCPCS code
G0507).
For CY 2018, the CPT Editorial Panel is creating CPT codes 99492,
99493, 99494, and 99484 to describe these services. For CY 2018, we are
adopting these CPT codes and deleting HCPCS codes G0502, G0503, G0504,
and G0507. We proposed the RUC-recommended work RVUs for each of these
CPT codes, which are identical to the current values for HCPCS codes
G0502, G0503, G0504, and G0507.
We proposed the RUC-recommended PE inputs, with one refinement. The
RUC-recommended values included clinical labor inputs in the facility
setting, but we did not propose to include these minutes in developing
the facility PE RVUs.
Were we to develop facility PE RVUs for these services that
included clinical staff time, when a practitioner working in a
provider-based department of a hospital was furnishing these services,
both the professional and the hospital would be paid for the same
clinical labor costs. We presumed that this aspect of the RUC's
recommendation reflects the circumstance where the patient receiving
the services spends a significant period of time in a facility setting,
but the billing practitioner is nonetheless incurring the cost
associated with the non-face-to-face clinical staff time over the
course of a month. We recognized that the binary site of service
differential may not recognize the different models of this kind of
care and may not be appropriate in some cases. We sought comments on
how to best address this valuation issue for these and other monthly
care management services. We noted that we could consider a range of
options for future rulemaking, including allowing separate billing for
the professional, technical, and global components of these services to
allow practitioners to bill the component of the service they furnish.
We stated in the CY 2017 PFS final rule (81 FR 80236) that the
general BHI code (CPT code 99484) may be used to report a range of
models of BHI services and that we expected this code to be refined
over time as we receive more information about other BHI models in use.
We remain interested in how this code is being used and look forward to
hearing from stakeholders regarding its use in reporting different
models of BHI services. Additionally, we have received inquiries from
stakeholders about whether or not professionals who cannot report E/M
services to Medicare might nonetheless serve as a primary hub for BHI
services. For example, stakeholders have suggested that a clinical
psychologist might serve as the primary practitioner that integrates
medical care and psychiatric expertise. For purposes of future
rulemaking, we sought comment on the circumstances under which this
model of care is happening and whether additional coding would be
needed to accurately describe and value other models of care.
Comment: A few commenters noted that the logic that would dictate a
lower PE RVU in a facility does not fit with the care management model
and one commenter also noted that patients in facility settings are
more medically and behaviorally complex. Some commenters stated that
they would be open to separate billing for the professional, technical,
and global components of these services in order to allow practitioners
to appropriately bill the component of the service they furnish and
preferred that option over not including clinical staff time in the
facility setting. One commenter suggested that CMS instruct
practitioners billing for these services to report the place of service
where they practice rather than the location of the patient.
Response: We will consider the commenters' input on solutions to
the site of service differential for care management services for
future notice and comment rulemaking. We also note that because these
codes describe services that take place over the course of a calendar
month, we have issued additional guidance, which can be found on the
CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/Behavioral-Health-Integration-FAQs.pdf.
Comment: A few commenters suggested that CMS create separate codes
to describe behavioral health care management services that could be
billed by psychologists and other non-physician practitioners who are
not authorized to bill Medicare for E/M services. One commenter
suggested that CMS include psychiatric diagnostic evaluation services
that can be furnished and billed by psychologists as eligible
initiating visits. Another commenter urged CMS to expand coverage to
make separate reimbursement to the psychiatric consultant in the
collaborative care model. Alternatively, another commenter noted that
integration of medical and psychiatric care requires the ability to
advise and make medical recommendations as needed for all relevant
medical care, including treatment for physical health conditions, which
may include psychiatric and other medical differential diagnosis,
treatment strategies regarding appropriate therapies, medication
management, and medical management of complications associated with
treatment of psychiatric disorders. Commenters also described other
models of care that are in use, including the STAR-VA model and a model
used in outpatient health care settings where a clinical social worker
not only provides psychiatric care but also assists with psychosocial
aspects of medical care.
Response: We thank commenters for their input and note that there
were several issues for which there was not stakeholder consensus. We
will consider all of the comments for future notice and comment
rulemaking.
For CY 2018, CMS is deleting the interim HCPCS codes G0502, G0503,
G0504, and G0507 and replacing them with CPT codes 99492, 99493, 99494,
and 99484, respectively. After consideration of these comments, for CY
2018, we are finalizing the coding and valuation for CPT codes 99492,
99493, 99494, and 99484, as proposed.
(58) Hyperbaric Oxygen Therapy (HCPCS Code G0277)
In the CY 2016 PFS final rule with comment period (80 FR 71005), we
discussed the CY 2015 valuation of hyperbaric oxygen therapy services
(79 FR 67677). Prior to CY 2015, CPT code 99183 was used to report both
the professional attendance and supervision, and the costs associated
with treatment delivery were included in the nonfacility direct PE
inputs for the code. We created HCPCS code G0277 to be used to report
the treatment delivery separately, consistent with the OPPS coding
mechanism, to allow the use of the same coding structure across
multiple settings. In establishing interim final direct PE inputs for
HCPCS code G0277, we used the RUC-recommended direct PE inputs for CPT
code 99183, which assumed a 120-minute treatment interval and adjusted
them to align with the 30-minute treatment interval of HCPCS code
G0277. We observed that the quantity of oxygen increased significantly
relative to the previous inputs for CPT code 99183.
To better understand why the oxygen supply increased, we reviewed
the instruction manual for the Sechrist Model 3600E Hyperbaric Chamber,
which was the model noted on the invoice that was included with the RUC
[[Page 53079]]
recommendations for use in pricing the capital equipment. The
instruction manual for the Sechrist 3600E model provided guidance
regarding the quantity of oxygen to be used in furnishing the service
described by HCPCS code G0277. Based on our review at that time, we
determined that 12,000 liters, rather than 47,000 liters, was the
typical number of units for the oxygen gas. Therefore, in aligning the
direct PE inputs as described in the CY 2016 final rule with comment
period, we first adjusted the units of oxygen to 12,000 liters for the
recommended 120 minute time, and subsequently adjusted it to align with
the 30-minute G-code by dividing by 4. We stated that we agreed that an
initial high purge flow rate is needed to reach maximum pressure/
O2; however, we still had not seen data that demonstrated
the need to continue the high purge flow rate throughout the entire
session. According to the manufacturer's instruction manual for this
model, ``once the nitrogen has been purged from the chamber and the
internal oxygen concentration has exceeded 95 percent, high flows are
no longer needed to maintain the patient's saturation level.'' The
manual also stated that ``the plateau purge flow can be set to 80
liters per minute (lpm).'' We calculated that 13 minutes at 400 lpm
plus 120 minutes at 80 lpm equals 14,800 liters of oxygen. We stated
that based on information in the manufacturer's manual that was
publicly available at the time, we believed that this represented the
typical usage for a 120-minute treatment. That amount represented an
increase from the interim final amount of 12,000 liters. We aligned
this total oxygen requirement to the 30-minute G-code by dividing
14,800 liters of oxygen by 4 and stated we were updating the direct PE
inputs to 3,700 liters of oxygen for HCPCS code G0277.
For CY 2018, we received requests from stakeholders to update the
direct PE inputs for HCPCS code G0277. In the CY 2016 PFS final rule
with comment period (80 FR 71005), we explained that we had previously
established values for this service based on information suggesting
that the Sechrist Model 3600E Hyperbaric Chamber was typically used in
furnishing the service in the non-facility setting. As we noted in that
rule, we established the amount of oxygen used in furnishing the
service based on use of the equipment item described as part of the RUC
recommendation, instead of the RUC-recommended amount of oxygen, which
appeared to be based on use of a different equipment product, the
Sechrist Model 3200. Based on information received from stakeholders,
we proposed in the CY 2018 PFS proposed rule to update both the
equipment item and the amount of oxygen so that the amount of oxygen
conforms to the RUC-recommended value of 47,600 liters of oxygen, which
we divided by 4 to conform to the 30-minute service period for HCPCS
code G0277, and that the equipment item is consistent with that
recommendation. The proposed direct PE inputs for HCPCS code G0277 were
displayed in the proposed CY 2018 direct PE input database, available
on the CMS Web site under the downloads for the CY 2018 PFS proposed
rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
We also proposed to exclude this change in direct PE inputs from
the calculation of the misvalued code target, since we viewed this
proposed change as a refinement of a single recommendation over several
years. Since the initial recommendation (79 FR 67677) was undertaken in
a year without the misvalued code target, we believed it would be
consistent with our previously established policy (80 FR 70923) to
exclude this change from the calculation. We noted that this change
would represent an increase from the current PE RVUs for this service.
Comment: Commenters were supportive of our proposal to update the
equipment item and the quantity of oxygen in the supply items for this
service.
Response: We appreciate the commenters' feedback.
After consideration of the comments received, we are finalizing the
direct PE inputs for HCPCS code G0277 as proposed. The direct PE inputs
for HCPCS code G0277 are displayed in the CY 2018 final rule direct PE
Input database, available on the CMS Web site under the downloads for
the CY 2018 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
(59) Payment Accuracy for Prolonged Preventive Services (HCPCS Codes
G0513 and G0514)
Many services paid under the PFS are coded to reflect differential
resource costs associated with different levels of care. However, this
level of granularity is not applied evenly across the PFS. For example,
there are far fewer E/M visit codes than there are codes that describe
procedures. While not a comprehensive solution to address the
differential resource costs of certain E/M visits, prolonged services
codes can be used to report medically necessary E/M visits that require
additional amounts of time. Like E/M visit codes, many of the Medicare-
covered preventive services codes describe a service that has an
atypically broad range of potential resource costs, including
differential amounts of time required to furnish services. However,
unlike for most E/M visit codes, there are not prolonged services codes
that apply to Medicare-covered preventive services.
Some stakeholders expressed concerns to CMS regarding the lack of a
coding mechanism for practitioners to report the additional time
sometimes required to appropriately furnish care to a patient receiving
a Medicare-covered preventive service. We noted that Medicare covers a
broad range of preventive services, such as a ``Welcome to Medicare
Preventive Visit'', yearly wellness visits, cancer screenings, and many
types of counseling. Medicare beneficiary coinsurance and deductible
payments are not applicable for certain Medicare-covered preventive
services. Additional information about preventive services covered
under Medicare, including whether beneficiary coinsurance or deductible
apply, is available on the CMS Web site at https://www.cms.gov/Medicare/Prevention/PrevntionGenInfo/Downloads/MPS-QuickReferenceChart-1TextOnly.pdf. To more accurately reflect the differential resource
costs when additional time is required to furnish a Medicare-covered
preventive service, we proposed to make payment for prolonged
preventive services using two new HCPCS G-codes that could be billed
along with the Medicare-covered preventive service codes, when a
clinician provides a prolonged Medicare-covered preventive service.
G0513: Prolonged preventive service(s) (beyond the typical
service time of the primary procedure) in the office or other
outpatient setting requiring direct patient contact beyond the usual
service; first 30 minutes (List separately in addition to code for
preventive service)), and
G0514: Prolonged preventive service(s) (beyond the typical
service time of the primary procedure) in the office or other
outpatient setting requiring direct patient contact beyond the usual
service; each additional 30 minutes (List separately in addition to
code for preventive service)).
We proposed that HCPCS codes G0513 and G0514 could only be billed
with Medicare-covered preventive services. Beneficiary coinsurance and
[[Page 53080]]
deductible would not be applicable for HCPCS codes G0513 and G0514
because the codes can only be reported to describe prolonged portions
of services where beneficiary coinsurance and deductible are not
applicable.
We proposed to create prolonged services codes in 30-minute
increments instead of the 60-minute increments that apply for the
parallel office/outpatient prolonged services codes, since some
Medicare-covered preventive services have a shorter duration than E/M
visits. For purposes of valuation for both initial and additional 30
minute codes, we proposed to use one half of the current work RVUs and
direct PE inputs for CPT code 99354 (Prolonged evaluation and
management or psychotherapy service(s) beyond the typical service time
of the primary procedure) in the office or other outpatient setting
requiring direct patient contact beyond the usual service; first hour
(List separately in addition to code for office or other outpatient
Evaluation and Management or psychotherapy service)). CPT code 99354
has a total time of 60 minutes and a work RVU of 2.33. Therefore, we
proposed a work RVU of 1.17 and 30 minutes of total work time for HCPCS
codes G0513 and G0514. We proposed to use one half of the direct PE
inputs for CPT code 99354, which resulted in a proposal of 7 minutes of
clinical labor type L037D (RN/LPN/MTA) and 15 minutes for equipment
type EF031 (table, power) for HCPCS codes G0513 and G0514 as the best
reflection of typical direct PE costs. We understood that these
specific clinical labor and equipment types may be functioning as proxy
inputs for some Medicare-covered preventive services.
We proposed that HCPCS codes G0513 and G0514 be billed for
prolonged preventive services beyond the typical service time of the
primary procedure. For preventive services with both physician work and
PE, we considered the typical service time of the primary procedure to
be the intraservice work time used for the purposes of PFS ratesetting.
For Medicare-covered preventive services with no face-to-face physician
work, the typical time is the service period clinical staff time that
best represents the face-to-face time with the patient. The counted
time guidelines (derived from the typical times assumed for PFS
ratesetting) for all eligible companion Medicare-covered preventive
services are available in the file called ``CY 2018 Preventive Services
Billed with Prolonged Preventives Code'' on the CMS Web site under
downloads for the CY 2018 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
Comment: Many commenters supported our proposal to pay separately
for prolonged preventive services. Commenters stated that by paying
separately for necessary additional time spent with patients during
preventive visits, CMS was both improving payment accuracy and
increasing accessibility to these services. Commenters also agreed with
our decision to only allow HCPCS codes G0513 and G0514 to be billed
with the preventive services where beneficiary coinsurance and
deductible are not applicable.
Response: We thank the commenters for their support of coding and
valuation for prolonged preventive services.
Comment: One commenter urged CMS to continue to work with the
disability community on innovative solutions as part of a broader
approach to ensuring equal health care access for people with
disabilities and suggested additional activities.
Response: We thank the commenter for the suggestions and look
forward to collaborating on other steps to improve access for people
with disabilities.
Comment: One commenter suggested that CMS allow HCPCS codes G0513
and G0514 to be billed with HCPCS code G0296 (Counseling visit to
discuss need for lung cancer screening using low dose CT scan), while
another commenter recommended that CMS expand use of these codes beyond
preventive services. One commenter requested that CMS allow HCPCS codes
G0513 and G0514 to be billed with HCPCS code G0447 (Face-to-face
behavioral counseling for obesity, 15 minutes). This commenter
expressed concern that there were very few cognitive services on the
list of eligible codes, yet the nature of a cognitive service may
require more time to furnish to a patient.
Response: We appreciate the commenters' interest in adding to the
types of services that can be billed with these codes. For many
services on the PFS, there are already coding mechanisms in place to
account for extra time spent with patients such as the CPT codes
available to account for prolonged E/M services (CPT codes 99354 and
99355). However, as we have previously noted, there continue to be
areas where we believe that current PFS coding may not accurately
reflect the differential resource costs associated with certain visits,
and we remain committed to working with beneficiaries, advocates, and
practitioners to continue to explore improvements in payment accuracy
for these services. To continue address this issue and to better align
coding and payment for prolonged E/M services with prolonged preventive
services, we proposed the above codes. As Medicare preventive services,
these codes may only be added on to other Medicare covered preventive
services for which there is also no applicable cost sharing.
With regard to HCPCS code G0447, we do not believe that HCPCS codes
G0513 and G0514 are coded to be applicable to timed services. We
welcome additional input from stakeholders regarding appropriate coding
and billing for these services and will consider addressing these
issues in future rulemaking. Finally, we note that HCPCS code G0296 is
eligible to be billed with prolonged preventive services.
Comment: Several commenters made specific suggestions as to the
format of the file CMS released with the typical times for eligible
preventive services. One commenter stated that releasing the file as a
download on the CY 2018 PFS final rule Web page was insufficient, and
that we should also include the typical times in the text of the CY
2018 PFS final rule as well. Another commenter stated that they
appreciated CMS releasing a file with the typical times, and encouraged
us to incorporate this information into other sources, such as the
Provider Payment Summary file.
Response: We appreciate these suggestions. We will make the file
with the typical times available via the downloads section of the CY
2018 PFS final rule as this is sufficiently accessible for
practitioners and stakeholders.
Comment: One commenter requested that CMS clarify whether it would
be able to bill the prolonged preventives codes if the additional time
was distributed across multiple services performed on a single
encounter.
Response: We believe that it would be appropriate to bill the
prolonged preventive services if all of the services performed are un-
timed preventive services with no beneficiary cost-sharing.
Comment: Several commenters provided suggestions as to how CMS
could further engage in outreach and guidance for practitioners. One
commenter provided feedback on the kinds of monitoring and
incentivizing activities CMS could undertake to advance beneficiary
access to these services.
[[Page 53081]]
Response: We thank commenters for their suggestions, and will
consider them for the future.
After consideration of comments received, we are finalizing our
proposal for prolonged preventive services using HCPCS codes G0513 and
G0514 with the work RVUs, work times, direct PE inputs, and
requirements for these codes as proposed.
(60) Physician Coding for Insertion and Removal of Subdermal Drug
Implants for the Treatment of Opioid Addiction (HCPCS Codes G0516,
G0517, and G0518)
We met with representatives from the American Society of Addiction
Medicine (ASAM) in April 2016 to discuss the possibility of making
separate payment for insertion and removal of buprenorphine
hydrochloride, formulated as a 4-rod, 80 mg, long-acting subdermal drug
implant for the treatment of opioid addiction. There are existing CPT
codes that broadly describe the insertion and removal of non-
biodegradable drug delivery implants (CPT codes 11981 through 11983).
However, ASAM contended that the resources associated with the
administration of this particular drug are greater than that of other
drug delivery implants, stating that the physician must insert four
rods using a newly designed applicator and obturator and use a
specially designed clamp to remove the four rods, which in some cases
requires careful shaving of tissue that has attached to the rods during
the 6-month period that the rods have been inserted. They noted that
these procedures can have unique challenges associated with treating
patients with opioid addiction, who often have complications and/or co-
morbidities. They also noted that the FDA has recognized the complexity
of the technology and patient needs by establishing regulatory
standards to adhere to the protocol and imposing special training
requirements on physicians. ASAM indicated that they would pursue an
application to the CPT Editorial Panel for new CPT codes.
ASAM informed CMS that the CPT Editorial Panel did not approve its
application; therefore, ASAM repeated its request that CMS establish
separate payment for the insertion, removal, and removal with
reinsertion of the buprenorphine subdermal implants.
To improve payment accuracy, for CY 2018, we proposed to make
separate payment for the insertion, removal, and removal with
reinsertion of Buprenorphine subdermal implants using HCPCS G codes:
HCPCS code G0516: Insertion, non-biodegradable drug
delivery implants, 4 or more.
HCPCS code G0517: Removal, non-biodegradable drug delivery
implants, 4 or more.
HCPCS code G0518: Removal with reinsertion, non-
biodegradable drug delivery implants, 4 or more.
For HCPCS code G0516, ASAM stated that performing the procedure
according to the FDA-required Risk Evaluation and Mitigation Strategies
(REMS) program takes approximately 23-25 minutes for the a physician
who is not a trainer/proctor for this procedure. They stated that in
developing crosswalk recommendations for physician work values, they
used a total time of 35-40 minutes, which is based on a preservice time
of 10 minutes, an intraservice time of 20-25 minutes, and a postservice
time of 5 minutes. Based on ASAM's recommendations, we proposed a work
RVU of 1.82 for HCPCS code G0516, which is supported by a direct
crosswalk to CPT code 64644 (Chemodenervation of one extremity; 5 or
more muscles).
For HCPCS code G0517, ASAM stated that data from physicians who
perform this procedure indicated that it takes approximately 15-20
additional minutes compared to the insertion procedure (HCPCS code
G0516) based on the FDA-required REMS program for removal of the
implant. ASAM noted that this procedure is of a higher intensity
compared to CPT code 11982 as this service requires identification and
removal of multiple subdermal implants. ASAM stated that in developing
crosswalk recommendations for physician work values, they used a total
time of 45-60 minutes, which is based on a preservice time of 10
minutes, an intraservice time of 30-45 minutes, and a postservice time
of 5 minutes. Based on ASAM's recommendations, we proposed a work RVU
of 2.10 for HCPCS code G0517, which is supported by a direct crosswalk
to CPT code 96922 (Laser treatment for inflammatory skin disease
(psoriasis); over 500 sq cm).
For HCPCS code G0518, ASAM indicated that there is minimal
consolidation of effort since the removal of the implants from one arm
is followed by insertion of a new set of implants in the contralateral
arm. Physician data from those who have performed this procedure
indicated that it takes approximately 70 minutes of total intra-service
time. ASAM stated that in developing crosswalk recommendations for
physician work values, they assumed a preservice evaluation time of 10
minutes (7 minutes for removal and 3 minutes for insertion),
positioning of 4 minutes (2 minutes for each arm), and wait time of 2
minutes (1 minute for each arm). ASAM stated that using the multiple
surgical procedure rule, they calculated an intraservice time of 40-58
minutes based on 100 percent of the intraservice time for HCPCS code
G0517 (30-45 minutes) and 50 percent of the intraservice time for HCPCS
code G0516 (0.5 x (20 - 25) = 10 - 13). ASAM used a postservice time of
8 minutes based on 100 percent of the postservice time for the removal
arm and 50 percent of the postservice time for the insertion arm,
equaling a total time of 58-76 minutes. Based on ASAM's
recommendations, we proposed a work RVU of 3.55 for HCPCS code G0518,
which is supported by a direct crosswalk to CPT code 31628
(Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when
performed; with transbronchial lung biopsy(s), single lobe).
We proposed to use the direct PE inputs requested by ASAM for HCPCS
codes G0516, G0517, and G0518, which are reflected in the Direct PE
Inputs public use files for clinical labor, supplies, and equipment,
available on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
In addition to seeking comment on the proposal to make separate
payment for these services using HCPCS codes, we also sought comment on
the appropriateness and accuracy of our proposed work RVUs and direct
PE inputs.
Comment: We received several comments on this proposal, which were
unanimously supportive. Commenters commended CMS for its ongoing
efforts to address the national opioid epidemic and ensure that
patients with substance use disorders have access to medically
necessary care.
Response: We appreciate the commenters' support of the proposal.
After consideration of the public comments, we are finalizing our
proposal for separate payment for insertion, removal, and removal with
reinsertion of Buprenorphine subdermal implants using HCPCS codes
G0516, G0517, and G0518, and the valuation for HCPCS codes G0516,
G0517, and G0518, as proposed.
(60) Superficial Radiation Treatment Planning and Management (HCPCS
Code GRRR1)
In the CY 2015 PFS final rule with comment period (79 FR 67666
through 67667), we noted that changes to the CPT prefatory language
limited the
[[Page 53082]]
codes that could be reported when describing services associated with
superficial radiation treatment (SRT) delivery, described by CPT code
77401 (radiation treatment delivery, superficial and/or ortho voltage,
per day). The changes effectively meant that many other related
services were bundled with CPT code 77401, instead of being separately
reported. For example, CPT guidance clarified that certain codes used
to describe clinical treatment planning, treatment devices, isodose
planning, physics consultation, and radiation treatment management
cannot be reported when furnished in association with superficial
radiation treatment. Stakeholders stated that these changes to the CPT
prefatory language prohibited them from billing Medicare for codes that
were previously frequently billed in addition to CPT code 77401. We
solicited comments as to whether the coding for SRT allowed for
accurate reporting of the associated services.
In the CY 2016 PFS final rule with comment period (80 FR 70955), we
noted that the RUC did not review the inputs for SRT procedures, and
therefore did not assess whether changes in valuation were appropriate
in light of the bundling of associated services. In addition, we
solicited recommendations from stakeholders regarding whether or not it
would be appropriate to add physician work for this service, even
though physician work is not included in other radiation treatment
services. As commenters were not in agreement as to whether the service
should be valued with physician work, we introduced the possibility of
creating a HCPCS G-code to describe total work associated with the
course of treatment for these services. The 2016 National Correct
Coding Initiative (NCCI) Policy Manual for Medicare Services stated
that radiation oncology services may not be separately reported with E/
M codes. While this edit is no longer active, stakeholders have stated
that MACs have denied claims for E/M services associated with SRT based
on the NCCI policy manual language. According to stakeholders, the
bundling of services associated with SRT, as well as the confusion
regarding the appropriate use of E/M coding to report associated
physician work, meant that practitioners were not being accurately paid
for planning and treatment management associated with furnishing SRT.
Due to these concerns regarding reporting of services associated
with SRT, in the CY 2018 PFS proposed rule, we proposed to make
separate payment for the professional planning and management
associated with SRT using HCPCS code GRRR1 (Superficial radiation
treatment planning and management related services, including but not
limited to, when performed, clinical treatment planning (for example,
77261, 77262, 77263), therapeutic radiology simulation-aided field
setting (for example, 77280, 77285, 77290, 77293), basic radiation
dosimetry calculation (for example, 77300), treatment devices (for
example, 77332, 77333, 77334), isodose planning (for example, 77306,
77307, 77316, 77317, 77318), radiation treatment management (for
example, 77427, 77431, 77432, 77435, 77469, 77470, 77499), and
associated E/M per course of treatment). We proposed for this code to
describe the range of professional services associated with a course of
SRT, including services similar to those not otherwise separately
reportable under CPT guidance and the NCCI manual. To value this code,
we included the physician work and time associated with radiation
management-related services that we think would be typical for a course
of SRT treatment. These services include: CPT code 77261 (Therapeutic
radiology treatment planning; simple), CPT code 77280 (Therapeutic
radiology simulation-aided field setting; simple), CPT code 77300
(Basic radiation dosimetry calculation, central axis depth dose
calculation, TDF, NSD, gap calculation, off axis factor, tissue
inhomogeneity factors, calculation of non-ionizing radiation surface
and depth dose, as required during course of treatment, only when
prescribed by the treating physician), CPT code 77306 (Teletherapy
isodose plan; simple (1 or 2 unmodified ports directed to a single area
of interest), includes basic dosimetry calculation(s)), CPT code 77332
(Treatment devices, design and construction; simple (simple block,
simple bolus)), and CPT code 77427 (Radiation treatment management, 5
treatments). Therefore, for CY 2018, we proposed a work RVU of 7.93 for
HCPCS code GRRR1. To develop the proposed direct PE inputs for this
code, we proposed to use the RUC-recommended direct PE inputs from the
aforementioned codes with several adjustments. We proposed to apply the
staff type ``RN/LPN/MTA'' for all of the clinical labor inputs for this
code because we believe that the typical office performing SRT would be
staffed with this labor type, rather than with another clinical labor
type such as radiation therapists, and we sought comment as to the
appropriateness of the staff type ``RN/LPN/MTA'' for this SRT-related
service. Some stakeholders have suggested that many services related to
SRT are personally performed by the billing practitioner rather than by
clinical staff. We proposed to remove the supply items ``gown,
patient'' and ``pillow case'' that are associated with CPT code 77280,
as these items are included in the minimum multispecialty visit pack
that is associated with CPT code 77427. We did not propose to include
the equipment items ``radiation virtual simulation system,'' ``room,
CT'' and ``PACS Workstation Proxy'' that are associated with CPT code
77280, as we do not believe that a typical office furnishing SRT uses
this kind of equipment. Instead, we included additional time for the
capital equipment used in delivering SRT in the proposed direct PE
inputs.
For ``radiation dose therapy plan,'' we proposed to apply the
clinical labor time that is associated with CPT code 77300 to HCPCS
code GRRR1 for purposes of developing a proposed value, but we sought
comment as to whether the clinical staff would typically perform the
radiation dose therapy planning for this service, or if the physician
would perform this and/or other tasks, and, in the case of the latter,
what the appropriate physician time would be. Likewise, we solicited
comment as to whether the clinical labor associated with the
teletherapy isodose plan would be performed by the physician. We
proposed to assign 14 minutes each to the equipment items ``radiation
therapy dosimetry software (Argus QC)'', ``computer workstation'', and
``3D teletherapy treatment planning'' as these are the times assigned
to these equipment items for CPT code 77300. We did not propose to
include inputs related to radiation physics consultation, described by
CPT code 77336, as we think that a typical course of SRT would not
require this service, and the typical practitioner providing SRT would
not be performing physics consultation, and we sought comment as to
whether inputs associated with this code or other inputs used in
furnishing analogous services should be included. We did not propose to
include the post-operative office visits included in the valuation of
CPT code 77427, as we did not believe that a typical course of SRT
would require post-operative visits; however, we solicited comment
regarding the amount of face-to-face time typically spent by the
practitioner with the patient for radiation treatment management
associated with SRT. As discussed in the CY 2016 PFS final rule with
comment period (80 FR 70924 through
[[Page 53083]]
70927), in the case of new codes that describe services that were
previously included in the payment for other codes, we finalized the
policy that these new codes are excluded from the misvalued code target
when they were previously bundled into a set of broadly reported E/M
codes and services that include E/M visits. We noted that we did not
believe that the change to separate payment for these kinds of services
should be counted as increases that are included in calculating ``net
reductions'' in expenditures attributable to adjustments for misvalued
codes. Therefore, we proposed to exclude HCPCS code GRRR1 from the
misvalued code target.
Comment: Many commenters did not support our proposal to make
separate payment for HCPCS code GRRR1 for CY 2018. These commenters
stated that our proposed valuation of HCPCS code GRRR1 would represent
a significant payment reduction for the associated services as compared
with the list of services that they are currently billing in
association with SRT. Many commenters stated that this new coding would
inhibit access to care for these services, discouraging the use of SRT
as a non-surgical alternative to Mohs surgery. Many suggested potential
coding solutions to these concerns, including: Our proposed G-code
should include inputs associated with more services, such as those
associated with the intermediate and complex codes for services such as
clinical treatment planning, simulating-aided field setting, and
treatment devices; our proposed code should include inputs for fewer
services; and the code for planning and management services associated
with SRT should be billable in multiple units such as for once per day
or once per lesion, rather than once for a full course of treatment as
proposed. Some commenters expressed preference for multiple G-codes
specific to each aspect of SRT delivery rather than a single bundle for
all associated SRT-related services. More specifically, some commenters
recommended three G-codes, representing treatment planning, treatment
devices, and treatment management. According to some commenters, our
proposal to value the planning and management services associated with
SRT with one code does not recognize variation in services related to
factors such as tumor type and location, and if the service is for skin
cancer or keloid scar. Commenters noted a preference that new coding
for these services should be developed through the CPT/RUC process.
Commenters also expressed concerns about specific direct PE inputs,
such as the clinical labor type assigned to HCPCS code GRRR1, stating
that radiation therapists, not the staff type ``RN/LPN/MTA'' should be
applied to this code. There was some disagreement among commenters
about whether or not qualified medical physicists (QMPs) would
typically be employed by dermatologists for SRT. A few commenters
supported our proposal to make payment for planning and management
services associated with SRT using HCPCS code GRRR1.
Response: We appreciate the comments. Given the various concerns
expressed by commenters, and the variety of potential solutions
offered, we are not finalizing our proposed separate payment and coding
for planning and management services associated with SRT at this time.
We expect to continue considering alternative solutions. The impetus
for making this proposal was based on our understanding that there are
limits to the appropriate reporting of professional services associated
with SRT, and the intent of this policy was to address gaps in what the
current coding allows for in relation to SRT. However, commenters have
indicated concerns with our proposed coding and valuation, including
access to care concerns; therefore. Therefore we believe additional
analysis is necessary and will further consider coding and payment for
professional services associated with SRT in light of commenter
concerns, and we are not establishing codes related to planning and
management services associated with SRT in this final rule. We look
forward to continuing our dialogue with stakeholders regarding the
appropriate coding and valuation for SRT-related professional services,
which we expect to address in future rulemaking.
Comment: Several commenters stated that CPT code 77401 is
undervalued and that it should be valued with a physician work
component.
Response: We note that our proposed G-code was designed, in part,
to address feedback that has indicated that the current coding,
including CPT code 77401, does not adequately account for the
professional services associated with SRT delivery. We did not propose
to value CPT code 77401, so we decline to do so now. We look forward to
addressing these potential coding gaps in future rulemaking.
After consideration of the comments received, we are not finalizing
our proposal to make separate payment for the planning and management
services associated with SRT using HCPCS code GRRR1. We will continue
our dialogue with stakeholders to address appropriate coding and
payment for professional services associated with SRT.
We note that we did not propose and are not making any changes to
the coding or valuation for CPT code 77401 (radiation treatment
delivery, superficial and/or ortho voltage, per day) in this final
rule. Providers can continue to bill CPT code 77401 as appropriate.
However, under the CPT guidance that has been in effect for several
years, certain codes used to describe clinical treatment planning,
treatment devices, isodose planning, physics consultation, and
radiation treatment management cannot be billed in addition to CPT code
77401. These planning and management codes, however, can continue to be
billed in addition to other codes involving other types of radiation
treatment, such as HCPCS code G6003 (Radiation treatment delivery,
single treatment area, single port or parallel opposed ports, simple
blocks or no blocks: up to 5 mev) and CPT code 77523 (Proton treatment
delivery; intermediate) in accordance with applicable guidance and
requirements.
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I. Evaluation & Management (E/M) Guidelines and Care Management
Services
In recent years, we have sought to recognize significant changes in
health care practice, especially innovations in the active management
and ongoing care of chronically ill patients. We have been engaged in
an ongoing incremental effort to identify gaps in appropriate coding
and payment for care management/coordination, cognitive services and
primary care within the PFS. This has included working with the CPT
Editorial Panel (CPT) to develop and value (or revalue) the following
service codes:
Transitional care management (TCM) services (2013).
Chronic care management services (CCM) (2015, 2017).
Behavioral health integration (BHI) services (2017).
Assessment/care planning services for cognitive impairment
(2017).
Prolonged E/M services without direct patient contact
(2017).
In response to public feedback regarding the initial implementation
of TCM and CCM, in the CY 2017 PFS final rule (81 FR 80225 through
80256), we finalized significant administrative burden reduction for
CCM and focused on limiting as much as possible the ways in which
Medicare's rules differed from the CPT guidance that generally applies
for all payers. We also worked with the CPT Editorial Panel and other
stakeholders to develop coding and improve payment accuracy for BHI,
cognitive impairment assessment/management, and prolonged services. In
the CY 2017 PFS final rule (81 FR 80255), we also reiterated our
commitment to addressing disparities for individuals with disabilities
and advancing health equity, and noted that we will continue to explore
improvements in payment accuracy for services furnished to individuals
with disabilities. We look forward to continued work with stakeholders
to ensure that the coding and valuation of these services accurately
reflects the resource costs involved in furnishing these services. In
the CY 2018 PFS proposed rule (82 FR 34078 through 34080), we solicited
public comments on ways we might further reduce administrative burden
for these and similar services under the PFS.
1. E/M Guidelines
a. Background
Most physicians and other billing practitioners bill patient visits
to the PFS under a relatively generic set of codes that distinguish
level of complexity, site of care, and in some cases, between new or
established patients. These codes are called Evaluation and Management
(E/M) visit codes. For example, there are generally three levels of
hospital and nursing facility inpatient E/M visit codes, and five
levels of office or hospital outpatient E/M visit codes, that vary
based on complexity. The latter also distinguish whether or not the
patient is new to the billing practitioner.
Billing practitioners must maintain information in the medical
record to document that they have reported the appropriate level of E/M
visit code. CMS maintains guidelines that specify the kind of
information that is required to support Medicare payment for each
level. According to these documentation guidelines, there are three key
components to selecting the appropriate level:
History of Present Illness (HPI or History);
Physical Examination (Exam); and
Medical Decision Making (MDM).
There are two versions of the documentation guidelines, commonly
referenced based on the year of their release (the ``1995'' and
``1997'' guidelines), available under downloads on the CMS Web site at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html. The most substantial differences between
the two sets of guidelines pertain to requirements for the physical
exam. The two versions have a slight difference in requirements for
documenting the history, and no difference in requirements for MDM. In
documenting a given E/M service, practitioners must use one version of
the guidelines or the other, with one exception related to extended
histories (see the Evaluation and Management Services guide available
on the CMS Web site at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/eval-mgmt-serv-guide-ICN006764.pdf). These guidelines are very similar to guidelines
within the CPT codebook for E/M visits. We provide an example of how
the guidelines distinguish between level 2 and level 3 visits in Table
17.
Stakeholders have long maintained that both the 1995 and 1997
guidelines are administratively burdensome and outdated with respect to
the practice of medicine, stating that they are too complex, ambiguous,
and that they fail to distinguish meaningful differences among code
levels. In general, we agree that there may be unnecessary burden with
these guidelines and that they are potentially outdated, and believe
this is especially true for the requirements for the history and the
physical exam. The guidelines have not been updated to account for
significant changes in technology, especially electronic health record
(EHR) use, which presents challenges for data and program integrity and
potential upcoding given the frequently automated selection of code
level.
Although CMS conducts few audits on E/M visits relative to the
volume of PFS services they comprise, we have repeatedly heard from
practitioners that compliance with the guidelines is a source of
significant audit vulnerability and administrative burden. Our prior
attempts to revise the guidelines met with a lack of stakeholder
consensus and support, which contributed to the current policy that
allows practitioners to use either the 1995 guidelines or 1997
guidelines, resulting in further complexity in determining or selecting
the applicable requirements.
b. E/M Guidelines Public Comment Solicitation
We continue to agree with stakeholders that the E/M documentation
guidelines should be substantially revised. We believe that a
comprehensive reform of E/M documentation guidelines would require a
multi-year, collaborative effort among stakeholders. We believe that
revised guidelines could both reduce clinical burden and improve
documentation in a way that would be more effective in clinical
workflows and care coordination. We also think updated E/M guidelines
coupled with technological advancements in voice recognition, natural
language processing and user-centered design of EHRs could improve
documentation for patient care while also meeting requirements for
billing and population health management. We recognize that achieving
the goal of reduced clinician burden and improved, meaningful
documentation for patient care will require both updated E/M
guidelines, as well as changes in technology, clinician documentation
practices and workflow. We solicited input from a broad array of
stakeholders, including patient advocates, on the specific changes we
should undertake to reform the guidelines, reduce the associated
burden, and better align E/M coding and documentation with the current
practice of medicine.
We specifically sought comment on how we might focus on initial
changes to the guidelines for the history and physical exam, because we
believe documentation for these elements may be more significantly
outdated, and that
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differences in MDM are likely the most important factors in
distinctions between visits of different levels. We also specifically
sought comment on whether it would be appropriate to remove our
documentation requirements for the history and physical exam for all E/
M visits at all levels. We stated that we believed MDM and time are the
more significant factors in distinguishing visit levels, and that the
need for extended histories and exams is being replaced by population-
based screening and intervention, at least for some specialties. In
addition, an increase in the utilization of EHRs, and to some extent,
shared health information via EHRs, may have changed the character of
extended patient histories since the guidelines were established. As
long as a history and physical exam are documented and generally
consistent with complexity of MDM, we believed there may no longer be a
need for us to maintain such detailed specifications for what must be
performed and documented for the history and physical exam (for
example, which and how many body systems are involved). We sought
comment on whether clinicians and other stakeholders believe removing
the documentation requirements for the history and physical exam would
be a good approach.
Although we believed that MDM guidelines may also need to be
updated, we stated our belief that in the near term, it may be possible
to eliminate the current focus on details of history and physical exam,
and allow MDM and/or time to serve as the key determinant of E/M visit
level. We sought public comment on this approach. We also sought
comment on how such reforms may differentially affect physicians and
practitioners of different specialties, including primary care
clinicians, and how we could or should account for such effects as we
examine this issue.
We noted that there may still be clinical or legal reasons for
individual practitioners to document an extended history or physical
exam (for example, where there are negative findings for certain body
systems in support of differential diagnosis). We additionally sought
comment on whether CMS should leave it largely to the discretion of
individual practitioners to what degree they should perform and
document the history and physical exam.
We also welcomed comments on specific ideas that stakeholders may
have on how to update MDM guidelines to foster appropriate
documentation for patient care commensurate with the level of patient
complexity, while avoiding burdensome documentation requirements and/or
inappropriate upcoding.
The following is a summary of the public comments received on the
E/M documentation guidelines, and our responses.
Comment: We received many comments on potential updates and
revisions to the E/M documentation guidelines. The comments described
ways in which the guidelines may be outdated or need to be improved
upon, for example to better reflect the content of E/M visit work,
team-based care and the advent of EHRs. The commenters were
appreciative and generally supportive of CMS undertaking this reform
effort. Many of the comments reflected agreement with CMS (and other
payers) that documentation standards are necessary to demonstrate and
provide a clear record of what was performed in support of payment, as
well as for legal and clinical reasons. However, commenters did not
agree on how the current standards should be changed, and different
specialties expressed different challenges and recommendations
regarding the guidelines. Many professional specialty associations
urged CMS to employ a more considered, long-term process such as a task
force rather than immediate changes.
There appeared to be some agreement among commenters that the
documentation requirements for history and physical exam are
particularly outdated. Commenters stated, for example, that they are
often required to include or cut-and-paste into the record extraneous
documentation detail regarding irrelevant history, review of unaffected
systems, and unnecessary (and in some cases burdensome to the patient)
physical exam elements, in order to justify an E/M code that most
adequately reflects their work. They stated that this information
bloats the medical record unnecessarily, increasing the time it takes
to find or convey to the reader the most important and relevant
clinical information at a given point in time. They said this detracts
significantly from spending time on more important patient care
activities.
A few commenters believe that the two elements of history and exam
could be eliminated entirely, while many commenters believe they needed
to be retained, but changed or rolled up somehow into MDM. Some
commenters believe that MDM is under-emphasized or could be assigned
greater weight, while still recognizing the critical role that history
and exam continue to play for patients, especially new patients. Some
commenters believe that new guidelines to support MDM-driven E/M
documentation need to be in place before requirements for history and
exam are eliminated. Some specialties (for example, hematology-oncology
and emergency medicine) explained that ensuring adequate performance
and documentation of both history and physical exam at every visit is
critical to their work for clinical, legal, operational, and other
reasons.
Some commenters raised the possibility of allowing flexibility at
the practitioner or organization level. For example, one commenter
suggested that CMS could encourage the use of unspecified standards,
while allowing individual physicians to decide what components of a
history and physical exam are required or should be documented for
individual patients. Some commenters believe there are clinical reasons
to include a history and exam in a patient's record, but they are not
needed to determine the E/M code level. Others advised CMS to eliminate
all numeric (counted) elements for history and exam in the
documentation guidelines and allow physicians to document only what is
relevant to the patient's specific diagnosis.
There was no consensus among commenters on changes that would need
to be made to MDM and time rules in order for CMS to rely more on these
elements (in lieu of history and exam) to justify service level billed.
Some commenters recommended clarification of ambiguities or more
uniform interpretation of the current MDM guidelines. Others believe
the existing criteria for assessing MDM are themselves inadequate, and
that while MDM should carry the most weight, it is the hardest to
measure meaningfully and is frequently subjective. Some commenters
recommended alternatives such as different MDM levels reflecting
comorbidity or the intensity of a single, highly active medical
condition. Some believe that MDM was a key determinant but not
sufficient to stand alone.
Some commenters sought clarification on what CMS was proposing with
respect to time. They were unclear how CMS envisioned time coming into
play in a different way than it currently does. Commenters had
differing views on the advisable role of time in determining code level
(alone or in combination with MDM). Some recommended expanding the role
of time, for example to enumerate time spent with family or spent
taking extended histories rather than just counseling time. Others
believe work should not be equated with time, or mentioned that relying
on
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time alone could create a perverse payment incentive.
Some commenters recommended, for immediate relief, that history and
exam should not be audited except where there is uncertainty regarding
MDM or lack of documentation regarding time. A few commenters suggested
alternative E/M service components such as the patient's functional
status, review of medications and care coordination. One commenter
listed several items they believe deserve CMS' review, even if there is
not a broad revision to the guidelines, including perceived overly
comprehensive history and exam requirements for the Level 4/5
differential; MDM rules that value a new problem higher than an
existing problem, even when it is clinically more minor; MDM rules that
do not distinguish medication risk according to how benign the
medication is; and the level of audit risk or exposure if less
information (history and exam) would be included in the medical record.
Some comments discussed the intersection of the guidelines with
EHRs. Some commenters requested alignment of EHR templates with new
guidelines, eliminating the need to cut-and-paste medical record
information, and eliminating information blocking to outside clinicians
(for example, pharmacists seeking information on patient history).
There was some support for removing requirements to document social,
family and past medical history in the medical record at a given visit
when it is already present within an EHR. Similarly, there was support
for only requiring full, baseline history and exam at time of first
visit/consultation, with updates at subsequent visits only to areas of
changes in condition that affect the treatment plan. There was also
some support for physicians being allowed to review and cross-
reference, or sign off on, certain documentation entered by ancillary
staff or technicians, entered directly by patients (such as through a
patient portal), or captured automatically by devices.
A number of commenters specified that changes should be effective
across all E/M codes of all levels. Some specialties requested
particular consideration of care settings other than just outpatient
care, such as inpatient or other transitional care settings.
Many commenters urged CMS to proceed cautiously by making changes
over a period of multiple years, using a representative task force and
additional public forums such as open door forums and listening
sessions prior to implementing broad changes. Some commenters suggested
that reforming the guidelines is a monumental task that would have a
far-reaching impact and needs to be done judiciously since, for
example, commercial payers often follow Medicare rules in this area.
These commenters stated that, if done correctly, revising the
guidelines will be a significant undertaking that is likely to last
several years and require an inclusive, transparent, iterative and
perhaps transitional process to ensure that all stakeholders across all
specialties are involved, that a thoughtful examination of options can
take place, and that the benefits and consequences of any potential
changes can be identified. Some commenters specified that the CPT
Editorial Panel, private insurers and EHR vendors should be involved.
Some commenters recommended clarification and training by CMS of
unspecified issues on interpretation of current guidelines, but
requested that CMS seek full input before moving forward with any
changes, including these clarifications. These commenters stated that
even minor changes to the codes or their documentation would require
physicians and practices a great deal of time to understand and
implement. A number of commenters asked CMS not to make any immediate
changes for these or similar reasons.
Response: We thank the commenters for this feedback. We are
especially appreciative of the commitment from stakeholders to work
with us on developing and implementing potential changes. We also note
that commenters frequently suggested that we provide additional avenues
for collaboration with stakeholders prior to implementing any changes.
We are currently considering the best approaches for such
collaboration, and will take the comments into account as we consider
the issues for future rulemaking.
In the CY 2018 PFS proposed rule (82 FR 34079), we further noted
that through letters, meetings, public comment letters in past
rulemaking cycles, and other avenues, we have heard from many
stakeholders that the E/M code set itself is outdated and needs to be
revised. For example, some stakeholders recommend an extensive research
effort to revise and revalue E/M services, especially the work inputs
(see 81 FR 46200). In prior rulemaking cycles, we acknowledged the
limitations of the current E/M code set. In our proposed rule, we
agreed that the structure of the underlying code set and its valuation
relative to other PFS services are also important issues that we expect
to continue to explore, though we stated our immediate focus on
revision of the current E/M guidelines in order to reduce unnecessary
administrative burden.
Comment: Some commenters requested that CMS undertake revision or
revaluation of the E/M code set itself, without further delay. Some
commenters expressed that the failure of the current code set to fully
capture cognitive work is more burdensome than the documentation rules
and, if addressed, would simultaneously address unnecessary
administrative burden. They stated that MDM is key to determining level
of service; however MDM is not just a critical documentation
requirement. In their view, it is also the critical piece to properly
define and value E/M services. Some commenters recommended that the
effort to revise documentation rules should be part of a broader
initiative to accurately reimburse physicians and other health
professionals for the work furnished during E/M visits, and that both
issues are important for transition to value-based payment as
physicians take on more accountability for their resource utilization.
Similarly, some commenters believe the code set itself is a separate
issue from the guidelines, but should be equally addressed by CMS and
the AMA/CPT Editorial Panel in the longer-term.
In contrast, other commenters believe that the current valuation of
all E/M services should be presumed correct, and that the goal of
reforming the guidelines is to make them consistent with current
medical practice. Several commenters recommended that CMS consider the
E/M definitional and valuation issues separate from E/M guideline
revision. They believe that changes in the guidelines should not
automatically require a review of current valuation. Also several
commenters asked CMS to reinstate the specialist consultation codes
that were discontinued for payment in 2010.
Response: We thank the commenters for this feedback. We believe the
public comments illustrate how difficult it is to utilize or rely upon
such a relatively small set of codes to describe and pay for the work
of a wide range of physicians and practitioners in many vastly
different clinical contexts. We also believe the public comments
illustrate that many of the issues with the E/M documentation
guidelines are not simply a matter of undue administrative burden. The
guidelines reflect how work was performed and valued a number of years
ago, and are intimately related to the definition and description of E/
M work as well as its valuation. Opinions on potential redefinition and
revaluation of the E/M code set tend to differ by specialty,
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according to the type of work dominating each specialty (for example,
primary care, so-called ``cognitive'' specialty work, or global
procedures that have E/M visits bundled in rather than separately
performed and documented). We expect to continue to work on all of
these issues with stakeholders in future years though we are
immediately focused on revision of the current E/M guidelines in order
to reduce unnecessary administrative burden.
2. Care Management Public Comment Solicitation
In the CY 2018 PFS proposed rule, we stated our continued interest
in the ongoing work of the medical community and other stakeholders to
refine the set of codes used to describe care management services. In
section II.H of this final rule, we discuss our final policy to adopt
CPT codes for CY 2018 to replace the G-codes we established for several
new care management service codes finalized last year, describing
cognitive impairment assessment and care planning, and behavioral
health integration services. In CY 2018, these codes will be added to
the suite of CPT care management service codes we adopted in recent
years, including transitional care management and chronic care
management (CCM) services. In our proposed rule, we also reiterated our
commitment to work with stakeholders on necessary refinements to this
code set, especially codes that would describe the professional work
involved in caring for complex patients in additional clinical
contexts. Also we solicited public comment on ways we might further
reduce the burden for practitioners reporting care management services,
including through stronger alignment between CMS requirements and CPT
guidance for existing and potential new care management service codes.
We received a few comments on ways CMS might further improve CCM
services, and approaches that CMS might take more broadly to improve
payment for care management services. In this section, we discuss the
comments and respond.
Comment: We received a few comments requesting a change in the
coding or payment for CCM services. Several commenters recommended that
CMS develop add-on codes to break out and pay for smaller clinical
staff time increments (specifically, breaking out increments of greater
than 20 minutes of clinical staff time, such as 21-40 minutes and 41-60
minutes).
Response: We appreciate the suggestion from commenters. At this
time, we generally intend to consider pursuing future changes to the
CPT codes describing chronic care management services, rather than
create new add-on G codes that would be used alongside current CPT
codes for CCM services. We urge stakeholders to work through the CPT
process to make needed changes or create new codes for the CCM code set
as appropriate.
Comment: One commenter recommended that CMS not require that a copy
of the care plan must be given to the patient (or caregiver as
appropriate). The commenter recommended that CMS instead require that a
copy of the plan of care must be available to the patient or caregiver.
Response: In the CY 2017 PFS final rule (81 FR 80250), we revised
this language to no longer mandate the format in which the care plan
must be provided (written versus verbal) and, rather, to allow the care
plan to be provided in a format consistent with patient/caregiver
preference. We stated that while beneficiaries must be provided a copy
of the care plan, practitioners may choose to provide the care plan in
hard copy or electronic form in accordance with patient preferences. We
believe our current language is more appropriate than the CPT language
or the language recommended by the commenter because it allows
flexibility in how the care plan information is transmitted to the
patient (or caregiver, if appropriate) in accordance with patient needs
or preference, but ensures to a greater degree that the information is
actually received by them, whatever the format. We believe a
requirement merely to make the information ``available'' may not ensure
that it is actually received and understood. If the patient (or
caregiver, if appropriate) prefers, the care plan may be provided to
them via an electronic portal. Also, whatever format is used to provide
the care plan, we expect that the care plan will be discussed with the
patient (and/or caregiver as appropriate) as part of the management of
their care and consistent with the other CCM scope of service elements.
Comment: One commenter recommended that CMS not require
documentation of each minute of service provided.
Response: In addition to CCM, there are many CPT codes that are
timed codes (having time within their code descriptor). The same rules
should apply for documentation of time for CCM as for other timed
services. For program integrity purposes (to ensure timed services are
actually performed in full, as described and defined by the code(s)),
we expect practitioners to document in the medical record how they
spent the qualifying time. In the case of CCM, they must document that
the required time was spent performing qualifying activities. This is
routine policy for timed service codes. If practitioners have specific
questions about the degree to which they must document and time their
CCM work using the current CPT codes, they should consult their
Medicare Administrative Contractor.
Comment: One commenter recommended that CMS reduce the service
elements for CPT code 99490 to require only one of the following
service elements to be performed: Comprehensive care management,
management of care transitions, or home- and community-based care
coordination.
Response: The current code descriptors and required scope of
service elements reflect the results of our notice and comment
rulemaking with significant contributions from the AMA/CPT Editorial
Panel. We believe we should continue to require, for each month in
which the service is billed, all of the service elements that are
medically necessary for the patient, which we believe is also
consistent with CPT reporting rules for CCM.
Comment: One commenter asked CMS to further align its rules with
CPT reporting rules by removing the requirement to use a certified EHR.
Response: We continue to believe that use of certified EHR
technology is vital to ensure that practitioners are capable of
providing the full scope of CCM services, such as timely care
coordination and continuity of care (see our prior discussion of this
issue at 79 FR 67723). The use of certified EHR technology helps ensure
that members of the interdisciplinary care team have timely access to
the patient's most updated health information. Also we believe that use
of certified EHR technology among physicians and other practitioners
will increase as we move forward to implement the Quality Payment
Program, including MIPS and Advanced Alternative Payment Models, as
well as other value-based payment initiatives. Accordingly, we are not
removing the requirement to use a certified EHR.
Comment: One commenter recommended that CMS not require an
initiating visit for any CCM patient. The commenter believes that
patient consent to receive CCM services could be obtained by a care
manager verbally by phone.
[[Page 53167]]
Response: Starting in CY 2017, we removed the requirement for all
CCM patients to receive initiating visits, instead only requiring it if
the patient has not been seen within a year prior to commencement of
CCM. Also we changed the consent requirement to allow verbal consent
(rather than the written consent we previously required) for all
patients, including patients who require an initiating visit. In other
words, consent can already be obtained verbally independent of the
initiating visit, as long as it is obtained prior to commencement of
the monthly CCM services. We continue to believe that if the patient
has not been seen within a year, there should be an initiating visit so
the billing practitioner can assess or re-assess the patient, gather
all necessary data to inform the care plan, and perform other
preparatory work. Therefore we are not changing this requirement. We
remind stakeholders that consent does not have to be obtained as part
of an initiating visit and can be done separately, as long as it is
obtained before the first CCM monthly service commences.
Comment: We received a few comments on the add-on code (G0506)
describing practitioner assessment and care planning in conjunction
with an initiating visit. One commenter said there should not be a
requirement for the billing practitioner to create the comprehensive
care plan as part of this code. The commenter believes their role
should instead be to identify and support patients during the
enrollment process, and to generally supervise the creation of the CCM
care plan. Another commenter recommended that CMS allow pharmacists to
have the care planning in HCPCS code G0506 delegated to them.
Response: We created HCPCS code G0506 explicitly to separately
identify and pay for the time and work of the billing practitioner
reporting the monthly CCM service, to ensure appropriate payment for
their comprehensive assessment and involvement at the outset of CCM, if
needed by the patient (81 FR 80245). We did this because we expect that
much of the subsequent CCM services will be performed incident to the
professional services of the billing practitioner and we wish to ensure
appropriate personal involvement of, and payment to, the practitioner
who is directly reporting CCM. The purpose for adopting this add-on
code was to describe and provide appropriate payment for work that is
personally and directly performed by the billing practitioner
themselves in preparation for furnishing CCM services. Care planning
that is performed by clinical staff incident to the services of the
billing practitioner may be counted towards the clinical staff time of
the monthly CCM service code(s), but cannot be counted towards G0506.
Comment: One commenter asked CMS to clarify that the CCM planning
code, HCPCS code G0506, can be billed on a day separate from an E/M
date of service.
Response: G0506 is comprised of a face-to-face assessment and care
planning personally performed only once by the practitioner reporting
the monthly CCM service, in conjunction with (as an add-on code to) an
initiating visit. The face-to-face assessment would be performed the
same day as the initiating visit, but some or all of the care planning
piece could be performed by the billing practitioner on a subsequent
day. Accordingly, we would expect the date of service for HCPCS code
G0506 on the claim to be the same as for the base initiating visit
code, and we will consider issuing an FAQ specifying this.
Comment: Several commenters recommended that CMS seek ways to
eliminate cost sharing for CCM and other care management services.
These commenters expressed that it is difficult to explain the
mechanics and benefits of care management to patients, given the added
cost sharing. They recommended that CMS seek ways to remove the cost
sharing, for example through designating the services as preventive
services or working with Congress to accomplish it legislatively.
Response: As we stated in our CY 2017 PFS final rule (81 FR 80240),
we appreciate the commenters' concerns and recognize many of the
challenges associated with patient cost sharing for these kinds of
services. At this time, we do not have authority to remove cost sharing
for care management services. We appreciate the commenters'
acknowledgement of our current limitations and we will continue to
consider this issue.
Comment: We received a few comments recommending ways in which we
might better involve specialists in the provision of CCM or care
management broadly (such as payment to emergency department physicians
when they act as primary care practitioners, or payment to multiple
practitioners involved in managing a given patient at a given time).
Also a few commenters recommended that CMS allow more than one
practitioner to bill CCM per month. They believe there were situations
where more than one practitioner co-manages a patient, or that
particularly complex patients who would benefit from CCM services also
benefit from seeing multiple health care providers.
Response: At this time, only one practitioner can report CCM per
month, consistent with both CPT guidance and the authorizing statute
for payment of CCM services (section 1848(b)(8)(B) of the Act).
However, we agree there may be circumstances in which more than one
practitioner expends resources managing or helping manage a CCM
patient. We will continue to explore ways in which we might better
identify and pay for costs incurred by multiple practitioners who
coordinate and manage a patient's care within a given month, and are
interested in hearing more about the relevant circumstances, potential
gaps in coding, and the exact nature of the work performed or costs
incurred.
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M. Therapy Caps
1. Outpatient Therapy Caps for CY 2018
Section 1833(g) of the Act (as amended by section 4541 of the
Balanced Budget Act of 1997) (Pub. L. 105-33) requires application of
annual per beneficiary limitations on the amount of expenses that can
be considered as incurred expenses for outpatient therapy services
under Medicare Part B, commonly referred to as ``therapy caps.'' There
is one therapy cap for outpatient occupational therapy (OT) services
and another separate therapy cap for physical therapy (PT) and speech-
language pathology (SLP) services combined. The therapy caps are
permanent, meaning that the statute does not specify an end date.
The therapy cap amounts under section 1833(g) of the Act are
updated each year based on the MEI. Specifically, the annual caps are
calculated by updating the previous year's cap by the MEI for the
upcoming calendar year and rounding to the nearest $10.00. Increasing
the CY 2017 therapy cap of $1,980 by the CY 2018 adjusted MEI of 1.4
percent and rounding to the nearest $10.00 results in a CY 2018 therapy
cap amount of $2,010.
An exceptions process for the therapy caps has been in effect since
January 1, 2006. Originally required by section 5107 of the Deficit
Reduction Act of 2005 (DRA), which amended section 1833(g)(5) of the
Act, the exceptions process for the therapy caps has been extended
multiple times through subsequent legislation as described in the CY
2015 PFS final rule with comment period (79 FR 67730). It was most
recently extended by section 202 of the Medicare Access and CHIP
Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10), and is set to
expire on December 31, 2017. The MACRA extension of the therapy cap
exceptions process includes the application of the therapy caps to
outpatient services furnished by hospitals described at section
1833(a)(8)(B) of the Act by continuing the temporary suspension under
section 1833(g)(6)(A) of the Act of the statutory exemption for these
hospital therapy services that first became effective October 1, 2012
through the enactment of the Middle Class Tax Relief and Jobs Creation
Act of 2012 (MCTRJCA) (Pub. L. 112-96).
CMS tracks each beneficiary's incurred expenses annually and counts
them toward the therapy caps by applying the PFS rate for each service
less any applicable multiple procedure payment reduction (MPPR) amount.
As required by section 1833(g)(6)(B) of the Act, added by section
603(b) of the American Taxpayer Relief Act of 2012 (ATRA) (Pub. L. 112-
240) and extended by subsequent legislation, the PFS-rate accrual
process is applied to outpatient therapy services furnished by CAHs
even though they are paid on a cost basis (effective January 1, 2014).
As we explained in the CY 2016 PFS final rule with comment period, we
use cost-based rates to track each beneficiary's incurred expenses
amounts for the outpatient therapy services furnished by the Maryland
hospitals paid under the Maryland All-Payer Model, currently being
tested under the authority of section 1115A of the Act (effective
January 1, 2016). After expenses incurred for the beneficiary's
outpatient therapy services for the year have exceeded one or both of
the therapy caps, therapy suppliers and providers use the KX modifier
on claims for subsequent services to request an exception to the
therapy caps. By using the KX modifier, the therapist is attesting that
the services above the therapy caps are reasonable and necessary and
that there is documentation of medical necessity for the services in
the beneficiary's medical record. Claims for outpatient therapy
services over the caps without the KX modifier are denied.
Since October 1, 2012, under section 1833(g)(5)(C) of the Act as
amended by the Middle Class Tax Relief and Jobs Creation Act of 2012
(MCTRJCA) (Pub. L. 112-96), we have been required to apply a manual
medical review process to therapy claims when a beneficiary's incurred
expenses for outpatient therapy services exceed a threshold amount of
$3,700. Just as there are two separate therapy caps, there are two
separate thresholds of $3,700, one for OT services and one for PT and
SLP services combined; and incurred expenses are counted towards these
thresholds in the same manner as the caps. Under section 1833(g)(5) of
the Act, as amended by section 202(b) of the MACRA, not all claims
exceeding the therapy thresholds are subject to a manual medical review
process as they were before. Instead, we are permitted to do a more
targeted medical review on these claims using factors specified in
section 1833(g)(5)(E)(ii) of the Act as amended by section 202(b) of
the MACRA, including targeting those therapy providers with a high
claims denial rate for therapy services or with aberrant billing
practices compared to their peers. The manual medical review process
required under section 1833(g)(5)(C) of the Act expires at the same
time as the exceptions process for therapy caps, on December 31, 2017.
For information on the manual medical review process, go to https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-Review/TherapyCap.html.
The statutory authority for the therapy caps exceptions process
will expire on December 31, 2017. Under current law, the therapy caps
will be applicable in accordance with the statute to all outpatient
therapy settings, except for services furnished and billed by
outpatient hospitals described under section 1833(a)(8)(B) of the Act.
Without a therapy caps exceptions process, the statutory limitation
requires that beneficiaries become financially liable for 100 percent
of expenses they incur for services that exceed the therapy caps. In
addition, without a therapy caps exceptions process, the therapy caps
will be applicable without any further medical review, and any use of
the KX modifier on claims for these services by providers of outpatient
therapy services will have no effect.
III. Other Provisions of the Proposed Rule
A. New Care Coordination Services and Payment for Rural Health Clinics
(RHCs) and Federally-Qualified Health Centers (FQHCs)
1. Overview
We have been engaged in a multi-year examination of coordinated and
collaborative care services in professional settings, and as a result
established codes and separate payment in the Physician Fee Schedule
(PFS) to separately recognize and pay for these important services. As
part of this initiative, the CY 2016 PFS proposed rule (80 FR 41708)
solicited public comments on (1) improving payment for the professional
work of care management services; (2) establishing separate payment for
collaborative care, particularly inter-professional consultation
between primary care physicians, psychiatrists, and other
practitioners; and (3) assessing whether current PFS payment for
Chronic Care Management (CCM) services is adequate and whether the
administrative burden associated with furnishing and billing these
services should be reduced.
As a result of the comments we received in response to our request,
we established in the PFS separate payment for complex CCM services,
and temporary codes to make separate payment for general behavioral
health integration (BHI) services and a psychiatric collaborative care
model (CoCM). We established four G codes to
[[Page 53170]]
describe BHI and psychiatric CoCM services and stated that we would
consider whether to adopt and establish values for any associated new
CPT codes being developed under our standard process once those codes
are active. The separate payment for complex CCM services, general BHI,
and psychiatric CoCM services were finalized in the CY 2017 PFS final
rule (81 FR 80225) beginning January 1, 2017, for practitioners billing
under the PFS. Based on these payments and codes, we proposed revisions
to the CCM payment for RHCs and FQHCs, and proposed requirements and
payment for general BHI and psychiatric CoCM services furnished in RHCs
and FQHCs, beginning on January 1, 2018.
2. Background
a. RHC and FQHC Payment Methodologies
RHC and FQHC visits are face-to-face encounters between a patient
and one or more RHC or FQHC practitioners during which time one or more
RHC or FQHC qualifying services are furnished. RHC and FQHC
practitioners are physicians, nurse practitioners (NPs), physician
assistants (PA), certified nurse midwives (CNMs), clinical
psychologists, and clinical social workers, and under certain
conditions, a registered nurse or licensed practical nurse furnishing
care to a homebound RHC or FQHC patient. A Transitional Care Management
(TCM) service can also be an RHC or FQHC visit, and a Diabetes Self-
Management Training (DSMT) service or a Medical Nutrition Therapy (MNT)
service furnished by a certified DSMT or MNT provider may also be an
FQHC visit. Only medically-necessary medical, mental health, or
qualified preventive health services that require the skill level of an
RHC or FQHC practitioner are RHC or FQHC billable visits. Services
furnished by auxiliary personnel (for example, nurses, medical
assistants, or other clinical personnel acting under the supervision of
the RHC or FQHC practitioner) are considered incident to the visit and
are included in the per-visit payment.
RHCs are paid an all-inclusive rate (AIR) for medically necessary
medical and mental health services and qualified preventive health
services furnished on the same day (with some exceptions). In general,
the A/B Medicare Administrative Contractor (MAC) calculates the AIR for
each RHC by dividing total allowable costs by the total number of
visits for all patients. Productivity, payment limits, and other
factors are also considered in the calculation. Allowable costs must be
reasonable and necessary and may include practitioner compensation,
overhead, equipment, space, supplies, personnel, and other costs
incident to the delivery of RHC services. The AIR is subject to a
payment limit, except for certain provider-based RHCs that have an
exception to the payment limit.
FQHCs were paid under the same AIR methodology until October 1,
2014, when, in accordance with section 1834(o) of the Act (as added by
section 10501(i)(3) of the Affordable Care Act), they began to
transition to an FQHC PPS system in which they are paid based on the
lesser of the FQHC PPS rate or their actual charges. The FQHC PPS rate
is adjusted for geographic differences in the cost of services by the
FQHC PPS geographic adjustment factor (GAF). The rate is increased by
34 percent when an FQHC furnishes care to a patient that is new to the
FQHC, or to a beneficiary receiving an Initial Preventive Physical
Examination (IPPE) or has an Annual Wellness Visit (AWV).
Both the RHC AIR and FQHC PPS payment rates were designed to
reflect the cost of all services and supplies that an RHC or FQHC
furnishes to a patient in a single day. The rates are not adjusted for
the complexity of the patient health care needs, the length of the
visit, or the number or type of practitioners involved in the patient's
care.
b. Current CCM Requirements and Payment for RHCs and FQHCs
In the CY 2016 PFS final rule with comment period (80 FR 71080), we
finalized policies for payment of CCM services in RHCs and FQHCs.
Payment for CCM services in RHCs and FQHCs was effective beginning on
January 1, 2016, for RHCs and FQHCs that furnish a minimum of 20
minutes of qualifying CCM services during a calendar month to patients
with multiple (two or more) chronic conditions that are expected to
last at least 12 months or until the death of the patient, and that
would place the patient at significant risk of death, acute
exacerbation/decompensation, or functional decline. The requirement
that RHC or FQHC services be furnished face-to-face was waived for CCM
services.
In the CY 2017 PFS final rule (81 FR 80256), we finalized revisions
to the CCM requirements for RHCs and FQHCs. Specifically, we revised
Sec. 405.2413(a)(5) and Sec. 405.2415(a)(5) to state that services
and supplies furnished incident to CCM and TCM services can be
furnished under general supervision of an RHC or FQHC practitioner,
consistent with Sec. 410.26(b)(5), which allows CCM and TCM services
and supplies to be furnished by clinical staff under general
supervision when billed under the PFS. We also revised requirements
pertaining to the provision of CCM services, consistent with the same
revisions for practitioners billing under the PFS to reduce the burden
of furnishing these services and promote beneficiary access to these
services. These revisions were effective beginning on January 1, 2017,
and included:
Revising the requirement that CCM be initiated during a
comprehensive evaluation and management (E/M), AWV, or IPPE visit, to
require a separately billable initiating visit only for new patients or
patients that have not had an E/M, AWV, or IPPE visit within the
previous year;
Revising the requirement that CCM services be available
24/7 with an RHC or FQHC practitioner who has access to the patient's
electronic care plan, to allow 24/7 access to auxiliary personnel with
a means to make contact with an RHC or FQHC practitioner;
Removing the restriction on faxing information, and no
longer requiring that care plan information be available on a 24/7
basis;
Removing the requirement that clinical summaries must be
formatted according to certified EHR technology, and instead requiring
that the RHC or FQHC create, exchange, and transmit continuity of care
document(s) in a timely manner with other practitioners and providers;
Removing the description of the format of the care plan
that is given to the patient or caregiver; and
Revising the requirement that RHCs and FQHCs obtain a
written agreement that the elements of CCM were discussed, to allowing
this information to be documented in the medical record.
In the CY 2017 PFS final rule, we stated that although CCM is
typically associated with primary care conditions, patient eligibility
is determined by the RHC or FQHC practitioner, and mental health
conditions are not excluded. We invited comments on whether an
additional code specifically for mental health conditions is necessary
for RHCs and FQHCs that want to include beneficiaries with mental
health conditions in their CCM services. We received a few comments
regarding mental health services in RHCs and FQHCs and appreciate the
information that was provided.
The 2016 and 2017 CCM payment rates for RHCs and FQHCs were set
annually based on the PFS national non-facility payment rate, and is
paid when CPT code 99490 is billed alone or with
[[Page 53171]]
other payable services on an RHC or FQHC claim. The 2017 rate for RHCs
and FQHCs is $42.71 for 20 minutes or more of CCM services. This is the
only RHC and FQHC service that has been paid in this manner, and RHCs
and FQHCs are not currently authorized to be paid for any other CCM or
other care management codes. Also, RHCs and FQHCs cannot bill for CCM
services for a beneficiary during the same service period as billing
for TCM or any other program that provides additional payment for care
management services (outside of the RHC AIR or FQHC PPS payment) for
the same beneficiary.
Additional information on CCM requirements is available on the CMS
Care Management Web page at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management.html and on the
CMS RHC and FQHC Web pages at https://www.cms.gov/Center/Provider-Type/Rural-Health-Clinics-Center.html and https://www.cms.gov/Center/Provider-Type/Federally-Qualified-Health-Centers-FQHC-Center.html.
c. Payment for Care Management Codes Under the PFS
CCM Services (CPT Code 99487 and CPT Code 99489)
As we stated in the CY 2017 PFS final rule (81 FR 80244), the
initial claims data for CCM services billed under the PFS showed that
although utilization was increasing steadily, use of CPT code 99490 was
still relatively low, and interviews with practitioners indicated that
many believed that they were exceeding the 20-minute time threshold for
billing this code. To pay as accurately as possible and to encourage
access to CCM services, the CY 2017 PFS final rule established separate
payment for two additional CCM codes, CPT code 99487 and CPT code
99489, effective beginning on January 1, 2017, for practitioners
billing under the PFS. These codes are for complex CCM services that
reflect additional clinical staff time, more extensive care planning,
and higher complexity of the patient.
CPT code 99487 is for complex CCM services. It requires multiple
(two or more) chronic conditions expected to last at least 12 months,
or until the death of the patient; chronic conditions that place the
patient at significant risk of death, acute exacerbation/
decompensation, or functional decline; establishment or substantial
revision of a comprehensive care plan; moderate or high complexity
medical decision making; and 60 minutes of clinical staff time directed
by a physician or other qualified health care professional, per
calendar month.
CPT code 99489 is for each additional 30 minutes of clinical staff
time directed by a physician or other qualified health care
professional, per calendar month.
Practitioners paid under the PFS can bill either complex (CPT code
99487 and CPT code 99489) or non-complex (CPT code 99490) CCM services
during a given service period, and can submit only one professional
claim for CCM services for that service period.
General BHI Services (HCPCS Code G0507)
The types of chronic conditions that are eligible for CCM services
are not specified and could include chronic mental health or behavioral
health conditions or chronic cognitive disorders as long as the CCM
requirements are met. However, because not all behavioral health issues
fit into the CCM model, and Medicare beneficiaries with behavioral
health conditions often require extensive care management discussions,
information-sharing, and planning between a primary care practitioner
and a behavioral health specialist, the CY 2017 PFS final rule
established HCPCS code G0507 for 20 minutes or more of general BHI
services. Payment for this code was effective beginning on January 1,
2017, for practitioners billing under the PFS. Effective January 1,
2018, HCPCS code G0507 is replaced by CPT code 99484.
BHI is a team-based, collaborative approach to care that focuses on
integrative treatment of patients with primary care and mental or
behavioral health conditions. As finalized in the CY 2017 PFS final
rule, requirements for this code include an initial assessment or
follow-up monitoring (including the use of applicable validated rating
scales); behavioral health care planning in relation to behavioral/
psychiatric health problems (including revision for patients who are
not progressing or whose status changes); facilitating and coordinating
treatment such as psychotherapy, pharmacotherapy, counseling and/or
psychiatric consultation; and continuity of care with a designated
member of the care team.
Psychiatric CoCM Services (HCPCS Codes G0502, G0503, and G0504)
Psychiatric CoCM is a specific model of care provided by a primary
care team consisting of a primary care provider and a health care
manager who works in collaboration with a psychiatric consultant. As
finalized in the CY 2017 PFS final rule, we provide Medicare payment
for psychiatric CoCM services to practitioners billing under the PFS
when these services are directed by a treating physician or other
qualified health care professional. We also finalized that the treating
physician or other qualified health care professional directs the
behavioral health care manager, who must be an individual with formal
education or specialized training in behavioral health, including
social work, nursing, or psychology, working under the oversight and
direction of the physician or qualified health care professional. We
finalized that a psychiatric consultant must be a medical professional
trained in psychiatry and qualified to prescribe the full range of
medications. Finally, psychiatric CoCM services may be furnished to
beneficiaries with any psychiatric or behavioral health condition(s)
and may include substance use disorders. The three psychiatric CoCM
codes established in the CY 2017 PFS final rule were G0502, G0503, and
G0504. Effective January 1, 2018, these codes are replaced by CPT codes
99492, 99493, and 99494, respectively.
HCPCS code G0502 is for 70 minutes or more of initial psychiatric
CoCM services in the first calendar month of behavioral health care
manager activities, in consultation with a psychiatric consultant, and
directed by the treating physician or other qualified health care
professional. Required elements include: outreach to and treatment of a
patient as directed by the treating physician or other qualified health
care professional; initial assessment of the patient, including
administration of validated rating scales, with the development of an
individualized treatment plan; review by the psychiatric consultant
with modifications of the plan, if recommended; entering of the patient
into a registry and tracking patient follow-up and progress using the
registry (with appropriate documentation), participation in weekly
caseload consultation with the psychiatric consultant; and provision of
brief interventions using evidence-based techniques such as behavioral
activation, motivational interviewing, and other focused treatment
strategies.
HCPCS code G0503 is for 60 minutes of subsequent psychiatric CoCM
services in a subsequent month and includes: Tracking patient follow-up
and progress using the registry (with appropriate documentation);
participation in weekly caseload consultation with the psychiatric
consultant; ongoing collaboration with and coordination of the
patient's mental health care with the treating physician
[[Page 53172]]
or other qualified health care professional and any other treating
mental health providers; additional review of progress and
recommendations for changes in treatment, as indicated, including
medications, based on recommendations provided by the psychiatric
consultant; provision of brief interventions using evidence-based
techniques (such as behavioral activation, motivational interviewing,
and other focused treatment strategies); monitoring of patient outcomes
using validated rating scales; and relapse prevention planning with
patients as they achieve remission of symptoms and/or other treatment
goals and are prepared for discharge from active treatment.
HCPCS code G0504 is for each additional 30 minutes of initial or
subsequent psychiatric CoCM services in a calendar month.
3. Proposed Care Management Requirements and Payment for RHCs and FQHCs
To ensure that RHC and FQHC patients have access to new care
management services in a manner consistent with the RHC and FQHC per
diem payment methodologies, we proposed the establishment of two new G
codes for use by RHCs and FQHCs. The first new G code, GCCC1, would be
a General Care Management code for RHCs and FQHCs, with the payment
amount set at the average of the national non-facility PFS payment
rates for CCM (CPT codes 99490 and 99487) and general BHI code G0507.
The second new G code for RHCs and FQHCs, GCCC2, would be a Psychiatric
CoCM code, with the payment amount set at the average of the national
non-facility PFS payment rates for CPT codes G0502 and G0503. (We note
that GCCC1 and GCCC2 were placeholder codes and are replaced by G0511
and G0512, respectively, effective January 1, 2018). The following is a
detailed discussion of our proposal, as well as alternatives that we
considered.
a. Proposed Establishment of a General Care Management Code for RHCs
and FQHCs
The RHC AIR and the FQHC PPS rate, which include all costs
associated with an RHC or FQHC visit, are based on the RHC's and FQHC's
costs. Although many RHCs and FQHCs have always provided some
coordination of care within and outside their facilities, the type of
structured care management services that are now billable under the PFS
are generally not included in the RHC AIR or the FQHC PPS rate. Because
CCM services are not required to be face-to-face encounters, and do not
require the skill level of an RHC or FQHC practitioner, they do not
meet the requirements for an RHC or FQHC billable visit. In addition,
RHC and FQHC services cannot be separately billed to the PFS.
Therefore, in the CY 2016 PFS final rule with comment period, we
established payment for CCM services at the PFS national non-facility
rate when CPT code 99490 is billed alone or with other payable services
on an RHC or FQHC claim to pay for the costs of CCM services that are
not already captured in the RHC AIR or the FQHC PPS payment.
When CCM services were first established for RHCs and FQHCs, CPT
code 99490 was the only CCM code that was billable under the PFS. Now
that there are additional codes for more complex CCM services and for
general BHI and psychiatric CoCM services, we believe it is necessary
to revise our payment approach for payment of care management services.
RHCs and FQHCs are paid per-visit rates that are not adjusted based
on the complexity of a service or the time spent furnishing services,
and the payment rate is not designed to be equal to the payment under
the PFS for a specific service. We sought to develop a methodology for
payment of care management services that is consistent with the RHC and
FQHC payment principles of bundling services and not paying for
services based on time increments. We also sought to develop a
methodology that would support the provision of care management
services without creating additional reporting burdens, while promoting
beneficiary access to comprehensive CCM and BHI services furnished by
RHCs and FQHCs.
Therefore, effective for services furnished on or after January 1,
2018, we proposed to create General Care Management code GCCC1 for RHCs
and FQHCs, with the payment amount set at the average of the 3 national
non-facility PFS payment rates for the CCM and general BHI codes and
updated annually based on the PFS amounts. The 3 codes are:
CPT 99490--20 minutes or more of CCM services
CPT 99487--at least 60 minutes of complex CCM services
HCPCS G0507--20 minutes or more of BHI services
RHCs and FQHCs could bill the new General Care Management code when
the requirements for any of these 3 codes (CPT codes 99490, 99487, or
HCPCS code G0507) are met. The General Care Management code would be
billed alone or in addition to other services furnished during the RHC
or FQHC visit. This code could only be billed once per month per
beneficiary, and could not be billed if other care management services
(such as TCM or home health care supervision) are billed for the same
time period. We note that CPT code 99489 is an add-on code when CPT
code 99487 is furnished, and is therefore not included as RHCs and
FQHCs are not paid for additional time once the minimum requirements
have been met.
As previously noted, the program requirements for RHCs and FQHCs
furnishing CCM services were established in the CY 2016 PFS final rule
with comment period (80 FR 71080) and revised in the CY 2017 PFS final
rule (81 FR 80256). We did not propose any changes to these
requirements at this time.
BHI refers to care management services that integrate behavioral
health services with primary care and other clinical services. To bill
for this service using the proposed General Care Management Code for
RHCs and FQHCs, 20 minutes or more of clinical staff time, directed by
an RHC or FQHC practitioner, must be furnished per calendar month. We
proposed the following requirements for RHCs and FQHCs furnishing BHI
services:
Initiating Visit: An E/M, AWV, or IPPE visit with an RHC
or FQHC primary care practitioner (physician, NP, PA, or CNM) occurring
no more than one-year prior to commencing BHI services. This could be
the same initiating visit that is used for initiating CCM services, and
would be billed separately as an RHC or FQHC visit (if the RHC or FQHC
has not already billed for this visit).
Beneficiary Consent: Documentation in the medical record
that the beneficiary has consented to receive BHI services, given
permission to consult with relevant specialists as needed, and been
informed that there may be beneficiary cost-sharing, including
deductible and coinsurance amounts as applicable, for both in-person
and non-face-to-face services that are provided. The beneficiary
consent process would also include informing the patient that only one
practitioner/facility can furnish and be paid for these services during
a calendar month, and that the patient can stop care coordination
services at any time (effective at the end of the calendar month). This
could be obtained at the same time that beneficiary consent is obtained
for CCM services.
Billing Requirements: At least 20 minutes of care
management services
[[Page 53173]]
per calendar month, furnished under the direction of the RHC or FQHC
primary care physician, NP, PA, or CNM, and furnished by an RHC or FQHC
practitioner, or by clinical personnel under general supervision. These
are the same billing requirements as for CCM services. If both CCM and
BHI services are furnished in the same month, the time would be
combined and billed as one under the new care coordination code.
Patient Eligibility: One or more new or pre-existing
behavioral health or psychiatric conditions being treated by the RHC or
FQHC primary care practitioner, including substance use disorders,
that, in the clinical judgment of the RHC or FQHC primary care
practitioner, warrants BHI services.
Required Service Elements: An initial assessment or
follow-up monitoring, including the use of applicable validated rating
scales; behavioral health care planning in relation to behavioral/
psychiatric health problems, including revision for patients who are
not progressing or whose status changes; facilitating and coordinating
treatment such as psychotherapy, pharmacotherapy, counseling and/or
psychiatric consultation; and continuity of care with a designated
member of the care team.
Both CCM and general BHI services are intended to provide a
structured and coordinated approach to care management that is not
typically included in the RHC's AIR or the FQHC PPS payment
methodology. Care management services are directed by the RHC or FQHC
primary care practitioner, who remains involved through ongoing
oversight, management, collaboration and reassessment, while care
management services are typically furnished in a non-face-to-face
setting primarily by a non-RHC or FQHC practitioner working under
general supervision requirements. Time spent by administrative or
clerical staff cannot be counted towards the time required to bill
these services.
Table 18 compares the proposed requirements for CCM and general BHI
services. We believe that even though there are some differences in the
requirements of CCM and general BHI, grouping them together will help
to promote integrated care management services for Medicare
beneficiaries who have either or both primary care and behavioral
health needs. It will also result in the least amount of reporting
burden for RHCs and FQHCs because once the 20-minute threshold is met
for either CCM or general BHI, reporting and tracking of additional
time increments is not required.
If this policy had been adopted for CY 2017, the payment amount for
General Care Management for RHCs and FQHCs would have been
approximately $61 (CPT 99490 at $42.71, + CPT 99487 at $93.67, + G0507
at $47.73 = $184.11/3 = $61.37). This is more than the CY 2017 PFS
national non-facility rates for CPT code 99490 and HCPCS code G0507,
and less than the PFS national non-facility rate for CPT code 99487. We
believe that this methodology is consistent with the RHC and FQHC
payment methodology of averaging costs to determine a payment rate
rather than paying for each individual service.
Table 18--Comparison of Proposed CCM and General BHI Requirements and
Payment for RHCs and FQHCs
------------------------------------------------------------------------
General BHI
Requirements CCM (CPT codes (proposed) (HCPCS
99490 and 99487) code G0507)
------------------------------------------------------------------------
Initiating Visit............ An E/M, AWV, or IPPE Same.
visit occurring no
more than one-year
prior to commencing
care coordination
services.
Furnished by a Same.
primary care
physician, NP, PA,
or CNM.
Billed as an RHC/ Same.
FQHC visit.
Beneficiary Consent......... Obtained during or Same.
after initiating
visit and before
provision of care
coordination
services by RHC or
FQHC practitioner
or clinical staff.
Written or verbal, Same.
documented in the
medical record
Includes
information:
On the
availability of
care coordination
services and
applicable cost-
sharing;
That only
one practitioner
can furnish and be
paid for care
coordination
services during a
calendar month;
That the
patient has right
to stop care
coordination
services at any
time (effective at
the end of the
calendar month);
and
That the Same.
patient has given
permission to
consult with
relevant
specialists.
Billing Requirements........ At least 20 minutes
of care
coordination
services per
calendar month that
is:
Furnished
under the direction
of the RHC or FQHC
primary care
physician, NP, PA,
or CNM; and.
Furnished Same.
by an RHC or FQHC
practitioner, or by
clinical personnel
under general
supervision.
Patient Eligibility......... Multiple (two or Any behavioral
more) chronic health or
conditions expected psychiatric
to last at least 12 condition being
months, or until treated by the RHC
the death of the or FQHC primary
patient, and place care practitioner,
the patient at including substance
significant risk of use disorders,
death, acute that, in the
exacerbation/ clinical judgment
decompensation, or of the RHC or FQHC
functional decline. practitioner,
warrants BHI
services.
[[Page 53174]]
Requirement Service Elements Includes: Includes:
Structured Initial
recording of assessment or
patient health follow-up
information using monitoring,
Certified EHR including the use
Technology and of applicable
includes validated rating
demographics, scales;
problems, Behavioral
medications, and health care
medication planning in
allergies that relation to
inform the care behavioral/
plan, care psychiatric health
coordination, and problems, including
ongoing clinical revision for
care;. patients who are
24/7 access not progressing or
to physicians or whose status
other qualified changes;
health care
professionals or Facilitating and
clinical staff coordinating
including providing treatment (such as
patients/caregivers psychotherapy,
with a means to pharmacotherapy,
make contact with counseling and/or
health care psychiatric
professionals in consultation); and
the practice to Continuity
address urgent of care with a
needs regardless of designated member
the time of day or of the care team.
day of week, and
continuity of care
with a designated
member of the care
team with whom the
patient is able to
schedule successive
routine
appointments;.
Comprehensive care
management
including
systematic
assessment of the
patient's medical,
functional, and
psychosocial needs;
system-based
approaches to
ensure timely
receipt of all
recommended
preventive care
services;
medication
reconciliation with
review of adherence
and potential
interactions; and
oversight of
patient self-
management of
medications;.
Comprehensive care
plan including the
creation, revision,
and/or monitoring
of an electronic
care plan based on
a physical, mental,
cognitive,
psychosocial,
functional, and
environmental
(re)assessment and
an inventory of
resources and
supports; a
comprehensive care
plan for all health
issues with
particular focus on
the chronic
conditions being
managed;
Care plan
information made
available
electronically
(including fax) in
a timely manner
within and outside
the RHC or FQHC as
appropriate and a
copy of the plan of
care given to the
patient and/or
caregiver;
Management
of care transitions
between and among
health care
providers and
settings, including
referrals to other
clinicians; follow-
up after an
emergency
department visit;
and follow-up after
discharges from
hospitals, skilled
nursing facilities,
or other health
care facilities;
timely creation and
exchange/transmit
continuity of care
document(s) with
other practitioners
and providers;
Coordination with
home- and community-
based clinical
service providers,
and documentation
of communication to
and from home- and
community-based
providers regarding
the patient's
psychosocial needs
and functional
deficits in the
patient's medical
record; and
Enhanced
opportunities for
the patient and any
caregiver to
communicate with
the practitioner
regarding the
patient's care
through not only
telephone access,
but also through
the use of secure
messaging,
Internet, or other
asynchronous non-
face-to-face
consultation
methods.
CY 2017 PFS Non-Facility CPT 99490--$42.71, G0507--$47.73.
Payment. CPT 99487--$93.67.
RHC/FQHC Payment for new Current: $42.71..... Current: N/A.
General Care Management G Proposed: Average of Proposed: Average of
code. CPT codes 99490, CPT codes 99490,
99487 and G0507 (If 99487 and G0507 (If
using the 2017 using the 2017
payment amounts, payment amounts,
this would be this would be
$61.37). $61.37).
------------------------------------------------------------------------
We expect that utilization of care coordination services will
continue to increase as more health care practices, including RHCs and
FQHCs, implement these services. Because the separate payments for the
complex CCM codes have only been implemented this year for
practitioners billing under the PFS, we do not have adequate data to
determine the frequency of billing for CCM codes CPT codes 99487 by
practitioners billing under the PFS compared with CPT code 99490.
Although billing practices may vary between physician offices and RHCs
and FQHCs (and within and between RHCs and FQHCs), we believe that
utilization patterns under the PFS can provide a reasonable proxy for
utilization practices in RHCs and FQHCs of care coordination
utilization. If the PFS data starts to show definitive trends in
billing certain CCM and BHI codes, or if data becomes available that
[[Page 53175]]
provides information on the extent of these services in RHCs and FQHCs,
we may consider using a weighted average in determining the payment
rate in the future. Similarly, if the proposal to create a new care
management code for RHCs and FQHCs is finalized, and any additional
care management codes become available on the PFS, we would review the
new codes to determine if they should also be factored into the RHC and
FQHC General Care Management Code. Any changes would be undertaken
through future rulemaking.
b. Proposed Establishment of a Psychiatric CoCM Code for RHCs and FQHCs
Psychiatric CoCM is a defined model of care that integrates primary
health care services with care management support for patients
receiving behavioral health treatment, and includes regular psychiatric
inter-specialty consultation with the primary care team, particularly
regarding patients whose conditions are not improving. We recognize
that the requirements of this model may be challenging for some RHCs
and FQHCs, especially those who have difficulty maintaining adequate
primary care and mental health staffing in rural and or underserved
areas. For those RHCs and FQHCs that choose to offer these services, we
believe this model may be particularly helpful, especially for patients
with primary care and mental health conditions who have not benefited
from standard treatment.
Effective for services furnished on or after January 1, 2018, we
proposed to create a psychiatric CoCM code for RHCs and FQHCs, GCCC2,
with the payment amount set at the average of the 2 national non-
facility PFS payment rates for CoCM codes, to be updated annually based
on the PFS amounts. The 2 codes are:
G0502--70 minutes or more of initial psychiatric CoCM services
G0503--60 minutes or more of subsequent psychiatric CoCM
services
RHCs and FQHCs could bill the new psychiatric CoCM code when the
requirements for any of these 2 codes (G0502 or G0503) are met. The
psychiatric CoCM code would be billed alone or in addition to other
services furnished during the RHC or FQHC visit. To prevent duplication
of payment, this code could only be billed once per month per
beneficiary, and could not be billed if other care management services,
including the proposed General Care Management code, are billed for the
same time period. We note that G0504 is an add-on code when G0503 is
furnished and is therefore not included as RHCs and FQHCs are not paid
for additional time once the minimum requirements have been met.
If this policy had been adopted for CY 2017, the payment amount for
psychiatric CoCM for RHCs and FQHCs would have been approximately
$134.58 (G0502 at $142.84 + G0503 at $126.33 = $269.17/2 = $134.58).
All care management services, including psychiatric CoCM, require a
separately billable initiating visit (E/M, AWV, or IPPE) for new
patients or beneficiaries not seen within 1 year prior to commencement
of care management services. Prior to commencement of psychiatric CoCM
services, the beneficiary must provide consent for this service,
including permission to consult with a psychiatric consultant and
relevant specialists. Advance consent must also include information on
cost sharing for both face-to-face and non-face-to-face services, and
acceptance of these requirements must be documented in the medical
record.
Patients with mental health, behavioral health, or psychiatric
conditions, including substance use disorders, who are being treated by
an RHC or FQHC practitioner, may be eligible for psychiatric CoCM
services, as determined by the RHC or FQHC practitioner. Psychiatric
CoCM services, like CCM and general BHI services, are intended to
provide a structured and coordinated approach to care management that
is not typically included in the RHC's AIR or the FQHC PPS payment
methodology.
The psychiatric CoCM team must include the RHC or FQHC
practitioner, a behavioral health care manager, and a psychiatric
consultant. Proposed specific requirements of the psychiatric CoCM team
are as follows:
Psychiatric CoCM Team--RHC or FQHC Practitioner
For psychiatric CoCM, the RHC or FQHC practitioner may be a primary
care physician, NP, PA, or CNM. The psychiatric CoCM requirements of
the RHC or FQHC practitioner are to:
Direct the behavioral health care manager and any other
clinical staff;
Oversee the beneficiary's care, including prescribing
medications, providing treatments for medical conditions, and making
referrals to specialty care when needed; and
Remain involved through ongoing oversight, management,
collaboration and reassessment.
Psychiatric CoCM Team--Behavioral Health Care Manager
For psychiatric CoCM, the behavioral health care manager is a
designated individual with formal education or specialized training in
behavioral health such as social work, nursing, or psychology. A
behavioral health care manager in an RHC or FQHC would be expected to
have a minimum of a bachelor's degree in a behavioral health field
(such as in clinical social work or psychology), or be a clinician with
behavioral health training, including RNs and LPNs. The behavioral
health care manager furnishes both face-to-face and non-face-to-face
services under the general supervision of the RHC or FQHC practitioner
and may be employed by or working under contract to the RHC or FQHC.
The psychiatric CoCM requirements of the behavioral health care manager
are:
Providing assessment and care management services,
including the administration of validated rating scales; behavioral
health care planning in relation to behavioral/psychiatric health
problems, including revision for patients who are not progressing or
whose status changes; provision of brief psychosocial interventions;
ongoing collaboration with the RHC or FQHC practitioner; maintenance of
the registry; acting in consultation with the psychiatric consultant;
Being available to provide services face-to-face with the
beneficiary; having a continuous relationship with the patient and a
collaborative, integrated relationship with the rest of the care team;
and
Being available to contact the patient outside of regular
RHC or FQHC hours as necessary to conduct the behavioral health care
manager's duties.
Psychiatric CoCM Team--Psychiatric Consultant
For CoCM, a psychiatric consultant is a medical professional
trained in psychiatry and qualified to prescribe the full range of
medications. The psychiatric consultant is not required to be on site
or to have direct contact with the patient and does not prescribe
medications or furnish treatment to the beneficiary directly. The CoCM
requirements of the psychiatric consultant are:
Participating in regular reviews of the clinical status of
patients receiving psychiatric CoCM services;
Advising the RHC or FQHC practitioner regarding diagnosis
and options for resolving issues with beneficiary adherence and
tolerance of behavioral health treatment; making
[[Page 53176]]
adjustments to behavioral health treatment for beneficiaries who are
not progressing; managing any negative interactions between
beneficiaries' behavioral health and medical treatments; and
Facilitating referral for direct provision of psychiatric
care when clinically indicated.
RHCs and FQHCs could bill the new psychiatric CoCM code, GCCC2,
when the requirements for HCPCS code G0502 or G0503 are met. This code
could only be billed once per month per beneficiary, and could not be
billed if other care management services, including the General Care
Management code GCCC1, are billed for the same time period.
As with the proposed General Care Management code GCCC1, we would
monitor PFS data to determine if a weighted average would be more
appropriate in determining the psychiatric CoCM payment rate for RHCs
and FQHCs, and whether any additional codes that may be added to the
PFS in the future should also be factored into the RHC and FQHC
psychiatric CoCM code. Any changes would be done through future
rulemaking.
Table 19 compares the proposed requirements for general BHI, which
would be billed using the proposed General Care Management code GCCC1,
and psychiatric CoCM services, which would be billed using the proposed
psychiatric CoCM code, GCCC2.
Table 19--Comparison of Proposed General BHI and Psychiatric CoCM
Requirements and Payment for RHCs and FQHCs
------------------------------------------------------------------------
Psychiatric CoCM
General BHI (proposed) (HCPCS
Requirements (proposed) (HCPCS code G0502 and
code G0507) G0503)
------------------------------------------------------------------------
Initiating Visit............ An E/M, AWV, or IPPE Same.
visit occurring no
more than one-year
prior to commencing
care coordination
services.
Furnished by a Same.
primary care
physician, NP, PA,
or CNM.
Billed as an RHC or Same.
FQHC visit.
Beneficiary Consent......... Obtained during or Same.
after initiating
visit and before
provision of care
coordination
services by RHC or
FQHC practitioner
or clinical staff.
Written or verbal, Same.
documented in the
medical record
Includes Same.
information:
On the
availability of
care coordination
services and
applicable cost-
sharing;
That only
one entity can
furnish and be paid
for care
coordination
services during a
calendar month;
That the
patient has the
right to stop care
coordination
services at any
time (effective at
the end of the
calendar month);
and
That the
patient has given
permission to
consult with
relevant
specialists.
Billing Requirements........ At least 20 minutes At least 70 minutes
of care management in the first
services per calendar month, and
calendar month that at least 60 minutes
is: in subsequent
Furnished calendar months of
under the direction psychiatric CoCM
of the RHC or FQHC services that is:
primary care Furnished
physician, NP, PA, under the direction
or CNM; and. of the RHC or FQHC
Furnished primary care
by an RHC or FQHC practitioner; and
practitioner, or by Furnished
clinical personnel by an RHC or FQHC
under general practitioner or
supervision. behavioral health
care manager under
general
supervision.
Patient Eligibility......... Any mental, Same.
behavioral health,
or psychiatric
condition being
treated by the RHC
or FQHC primary
care practitioner,
including substance
use disorders,
that, in the
clinical judgment
of the RHC or FQHC
practitioner,
warrants BHI
services.
Requirement Elements........ Includes: Includes:
Initial RHC or FQHC primary
assessment or care practitioner:
follow-up Direct the
monitoring, behavioral health
including the use care manager or
of applicable clinical staff;
validated rating Oversee the
scales. beneficiary's care,
Behavioral including
health care prescribing
planning in medications,
relation to providing
behavioral/ treatments for
psychiatric health medical conditions,
problems, including and making
revision for referrals to
patients who are specialty care when
not progressing or needed; and
whose status Remain
changes. involved through
ongoing oversight,
Facilitating and management,
coordinating collaboration and
treatment (such as reassessment.
psychotherapy, Behavioral Health
pharmacotherapy, Care Manager:
counseling and/or Provide
psychiatric assessment and care
consultation). management
Continuity of care services, including
with a designated the administration
member of the care of validated rating
team. scales; behavioral
health care
planning in
relation to
behavioral/
psychiatric health
problems, including
revision for
patients who are
not progressing or
whose status
changes; provision
of brief
psychosocial
interventions;
ongoing
collaboration with
the RHC or FQHC
practitioner;
maintenance of the
registry; acting in
consultation with
the psychiatric
consultant;
[[Page 53177]]
Be
available to
provide services
face-to-face with
the beneficiary;
having a continuous
relationship with
the patient and a
collaborative,
integrated
relationship with
the rest of the
care team; and
Be
available to
contact the patient
outside of regular
RHC or FQHC hours
as necessary to
conduct the
behavioral health
care manager's
duties.
Psychiatric
Consultant:
Participate
in regular reviews
of the clinical
status of patients
receiving CoCM
services;
Advise the
RHC or FQHC
practitioner
regarding
diagnosis, options
for resolving
issues with
beneficiary
adherence and
tolerance of
behavioral health
treatment; making
adjustments to
behavioral health
treatment for
beneficiaries who
are not
progressing;
managing any
negative
interactions
between
beneficiaries'
behavioral health
and medical
treatments; and
Facilitate
referral for direct
provision of
psychiatric care
when clinically
indicated.
Cy 2017 PFS Non-Facility G0507--$47.73....... G0502--$142.84,
Payment. G0503--$126.33.
RHC/FQHC Payment for New Current: N/A........ Current: N/A.
Psychiatric CoCM G Code. Proposed: Average of Proposed: Average of
CPT codes 99490, HCPCS codes G0502
99487, and G0507. and G0503. (If
(If using the 2017 using the 2017
payment amounts, payment amounts,
this would be this would be
$61.37). $134.58).
------------------------------------------------------------------------
c. Other Options Considered
We considered allowing RHCs and FQHCs to bill for the complex CCM
codes, the BHI code, and the psychiatric CoCM codes by allowing the
individual CPT or HCPCS codes to be billed on an RHC or FQHC claim, in
the same manner as we currently allow CPT code 99490 to be billed on a
claim. We do not believe this approach is in the best interest of RHCs
and FQHCs. There are now 5 separate care management codes that are
applicable to RHCs and FQHCs, and more codes could be added in the
future as we learn more about the benefits of non-face-to-face care
management services. Each of these codes has specific time increments
that must be tracked and reported for payment under the PFS. We believe
that grouping the CCM and BHI codes and the psychiatric CoCM codes into
2 G codes is more consistent with the RHC and FQHC payment methodology
of averaging actual costs to determine a payment rate and not paying
for services based on time increments. It also requires less record
keeping, monitoring, and coding expertise, while maintaining the same
quality of care standards.
We also considered grouping all 5 codes together into one G code,
or developing 3 G codes--one for the CCM codes, one for the BHI code,
and one for the psychiatric CoCM codes. We did not choose either of
these approaches because CCM and BHI are similar services that
complement each other, and grouping them together is consistent with an
integrated approach to care with reduced reporting requirements. We
also believe that psychiatric CoCM is different enough from both CCM
and BHI in its requirements, particularly in staffing and required
services, that it warrants a separate G code. We believe that our
proposal of creating 2 new G codes to encompass the 5 care management
codes is the best option for RHCs and FQHCs now and in the future if
new care management codes are developed. We welcomed comments on the
proposal.
The following is a summary of the public comments received on our
proposal to revise the CCM payment for RHCs and FQHCs and establish
requirements and payment for general BHI and psychiatric CoCM services
furnished in RHCs and FQHCs, beginning on January 1, 2018. As
previously noted, the following code changes will be effective January
1, 2018, and are used in the remainder of this rule:
Table 20--Comparison of Proposed and Final HCPCS/CPT Codes
----------------------------------------------------------------------------------------------------------------
Final HCPCS/CPT code (effective
Description of code Proposed or current HCPCS/CPT code January 1, 2018)
----------------------------------------------------------------------------------------------------------------
General Care Management for RHCs GCCC1 G0511
and FQHCs only.
Psychiatric CoCM code for RHCs and GCCC2 G0512
FQHCs only.
Psychiatric CoCM Services (first G0502 99492
70 min).
Psychiatric CoCM Services G0503 99493
(subsequent 60 min).
Psychiatric CoCM Services (add on) G0504 99494
General BHI Services.............. G0507 99484
----------------------------------------------------------------------------------------------------------------
[[Page 53178]]
Comment: Most commenters were supportive of our proposal. Many
commenters stated that these changes will increase the availability of
CCM, BHI, and psychiatric CoCM in RHCs and FQHCs and increase access
for patients who need these services, especially in rural areas. Many
commented that the proposal will support efforts to integrate medical
and behavioral health care and encourage more primary care and
behavioral health care providers to work together and coordinate care
to better assist patients with complex, chronic conditions. Many
commented on the role of RHCs and FQHCs as safety net providers serving
the Nation's most vulnerable populations, and how important care
management services are, especially for individuals with complex needs
and few resources. A few commenters expressed their preference for
billing each service by separate CPT codes, but most stated that the
proposed methodology is administratively simple, will reduce reporting
burden, and is in alignment with current RHC and FQHC billing
practices. Many commenters also noted that this proposal will build
upon efforts at addressing substance abuse and the opioid epidemic,
increasing obesity rates, traumatic brain injury, dementia, and the
health care needs of an aging population.
Response: We thank the commenters for their support of the
proposal.
Comment: Some commenters noted that patients are often unwilling to
pay the patient share of care management services and requested CMS
waive cost-sharing or pursue waivers for these codes.
Response: We are aware that the copayment and/or deductible in RHCs
and the copayment in FQHCs can be a barrier for some beneficiaries, but
we do not have the statutory authority to waive these charges. Because
these services are typically furnished non face-to-face, and therefore,
are not visible to the patient, it is important that adequate
information is provided during the consent process on cost-sharing
responsibilities and the benefits of care management services. RHCs and
FQHCs should also provide information on the availability of assistance
to qualified patients in meeting their cost-sharing obligations, or any
other programs to provide financial assistance, if applicable.
Comment: Several commenters asked if psychiatric mental health
nurse practitioners (PMH-NPs) could serve as the psychiatric consultant
to RHCs and FQHCs that are furnishing psychiatric CoCM, and recommended
that they be included based on their education and training or board
certification. Some commenters stated that this is especially important
in rural areas where specialists are not readily available, and others
stated that this would make psychiatrists more readily available for
patients for which a higher degree of training may be required.
Response: The psychiatric CoCM program requires a psychiatric
consultant who is a medical professional trained in psychiatry and
qualified to prescribe the full range of medications. Their
responsibilities include participating in regular reviews of the
clinical status of patients receiving psychiatric CoCM services;
advising the RHC or FQHC practitioner regarding diagnosis and options
for resolving issues with beneficiary adherence and tolerance of
behavioral health treatment; recommending adjustments to behavioral
health treatment for beneficiaries who are not progressing; managing
any negative interactions between beneficiaries' behavioral health and
medical treatments; and facilitating referral for direct provision of
psychiatric care when clinically indicated.
PMH-NPs are trained to provide a wide range of mental health
services, including psychiatric diagnosis and medication treatment for
psychiatric disorders. Although NPs are authorized to prescribe
controlled substances, their practice authority varies by state and in
some states they may have additional requirements or restrictions. We
believe that a board-certified PMH-NP would meet the requirements to
serve as a psychiatric consultant for an RHC or FQHC that is furnishing
psychiatric CoCM services and would assist in making this program more
widely available, especially in rural areas.
Comment: Several commenters requested clarification or removal of
the requirement that the psychiatric CoCM behavioral health care
manager be available to contact the patient outside of regular RHC or
FQHC hours as necessary to conduct the behavioral health care manager's
duties. Commenters questioned if this meant that the health care
manager must be available 24/7, and if so, they noted this was an
unreasonable expectation that would present a barrier to implementing
this program.
Response: RHCs and FQHCs have processes for patients to contact
practitioners or access care during non-RHC or FQHC hours, and it was
not our intention to require or imply that the behavioral health care
manager be available on a 24/7 basis. To avoid any confusion, this
requirement will be removed.
Comment: Several commenters requested clarification of the
qualifications for the behavioral health care manager. One commenter
questioned whether a social worker could serve in this role or if a
master level clinical social worker is required. Another commenter
stated that some of the health care manager's duties, such as
administering screening tools, scheduling meetings, and entering data
for the registry, could be conducted by someone with less education,
under the supervision of a licensed practitioner. Other commenters
suggested that licensed clinical social workers, licensed clinical
professional counsellors, licensed or bachelor level social workers,
nurses who undergo mental health training or have some experience in
psychiatric interviewing, certified addiction counselors, or
occupational therapists should be able to serve as the behavioral
health care manager.
Response: As noted in the proposed rule, the behavioral health care
manager is a designated individual with formal education or specialized
training in behavioral health such as social work, nursing, or
psychology. A behavioral health care manager in an RHC or FQHC would be
expected to have a minimum of a bachelor's degree in a behavioral
health field (such as in clinical social work or psychology), or be a
clinician with behavioral health training, including RNs and LPNs.
Therefore, a clinical social worker is not required to have a masters
degree in social work to serve as the psychiatric CoCM health manager.
It is the responsibility of the RHC or FQHC to assure that the
behavioral health care manager meets the stated requirements, and to
manage any delegation of duties and supervision as appropriate.
Comment: Some commenters objected to the requirement that general
BHI and psychiatric CoCM services be furnished only under the direction
of an RHC or FQHC primary care physician, NP, PA, or CNM, and
maintained that excluding CPs and CSWs would create a barrier to
effective team-based care.
Response: General BHI and psychiatric CoCM are both team-based,
collaborative approaches to care that focus on integrative treatment of
patients with primary care and mental or behavioral health conditions.
General BHI was established to support extensive care management
discussions, information-sharing, and planning between a primary care
practitioner and a behavioral health specialist, while psychiatric CoCM
is a specific model of care provided by a primary care team
[[Page 53179]]
consisting of a primary care provider and a health care manager who
works in collaboration with a psychiatric consultant.
CPs and CSWs are RHC and FQHC practitioners and furnish medically-
necessary, face-to-face services that may be stand-alone billable
visits in RHCs and FQHCs. They can also serve as the behavioral health
care manager for general BHI and psychiatric CoCM services. In order to
facilitate the integration and coordination of the patient's primary
care and mental or behavioral health conditions, these care management
services are furnished under the direction of the RHC or FQHC primary
care practitioner.
Comment: One commenter suggested that the consulting psychiatrist
on the psychiatric CoCM team should be able to bill separately for this
service in addition to the payment to RHCs and FQHCs. Other commenters
suggested that CPs and CSWs, or the entire behavioral health workforce,
be able to bill directly for these services.
Response: The consulting psychiatrist is a member of the
psychiatric CoCM team, and the RHC and FQHC payment reflects the cost
of their services. If the consulting psychiatrist were to bill
separately, Medicare would be overpaying for this service, because the
cost of the psychiatric consultant is included in the rate for the care
management codes. We also note that services are billed by the RHC or
FQHC, and that neither RHC, FQHC practitioners (including CPs and
CSWs), nor any other clinical personnel, bill directly for services
furnished in RHCs or FQHCs.
Comment: One commenter supported the proposed methodology but noted
more needs to be done to create coding options and reimbursement for
consultation models where a child and adolescent psychiatrist guides a
primary care physician in treating behavioral and mental health
conditions. The commenter stated that these models help to ensure that
more children and youth in need of behavioral or mental health
interventions receive the care they need and are an efficient way to
address severe child and adolescent psychiatrist workforce shortages in
most areas of the country.
Response: We agree that there are many children and adolescents in
need of behavioral or mental health interventions and that many areas
of the country do not have adequate psychiatric services for children
and adolescents, but this is outside the scope of this proposal.
Comment: A commenter noted that RHCs and FQHCs would receive a
higher payment for CPT 99490 services than an office-based practice,
and as a result, this code should be revalued.
Response: The proposed payment methodology for general care
management services furnished by RHCs and FQHCs is similar to the
payment methodology for other RHC and FQHC services. In general, RHCs
and FQHCs are paid a per diem rate that is based on average costs, and
the payment is not adjusted for time or intensity once the requirements
are met. This results in a payment rate that is sometimes less and
sometimes more than the payment for the same services when it is billed
by an office-based practice under the PFS. We respectfully disagree
that the proposed RHC and FQHC payment for general care management is a
reason to revalue CPT 99490, and note that if any of the codes that are
included in G0511 (CPT codes 99490, 99487, and 99484) are revalued, the
payment for G0511 would adjust accordingly.
Comment: One commenter expressed concern that RHCs and FQHCs may
not offer care management services because the care management codes
can be used only once per month for a beneficiary and cannot be
combined with other care management codes. This commenter urged us to
remove these restrictions and instead actively monitor the use of these
codes to determine whether overuse occurs.
Response: While we appreciate the commenter's concern, we
respectfully disagree that limiting the billing of these codes to once
per month will impede an RHC or FQHC from offering these services. The
payment methodology is designed to encourage the use of these services
by making billing and record keeping as simple as possible while
providing a favorable payment rate. Once the minimum requirements are
met, RHCs and FQHCs can bill for this service and would be paid at the
average rate of the applicable codes, whether or not additional time is
spent furnishing these services. We believe this approach is likely to
encourage RHCs and FQHCs to offer these services and is preferable to
actively monitoring for overuse.
Comment: One commenter agreed with our intention to monitor the
frequency of PFS billing for CPT 99487 to determine whether a weighted
average would be more appropriate for future payment years, and
suggested that we also monitor the extent that complex chronic care
management services are provided in RHC and FQHCs.
Response: We appreciate the comment and will review all available
data to determine if a weighted average would be more appropriate in
the future. As we noted in the proposed rule, any changes would be
undertaken through future rulemaking.
Comment: One commenter noted that for low-income or limited-English
proficiency Medicare beneficiaries, care management can lead to more
effective care, better health outcomes and fewer emergency department
visits. This commenter suggested that the additional costs of providing
appropriate care for these populations should be acknowledged and
payments appropriately adjusted in future rulemaking. Another commenter
was concerned that the proposed methodology may not accurately reflect
and compensate RHCs and FQHCs for the additional complexity of care
coordination for patients who have significant primary care needs and
requested that we consider comments received from health care providers
and patient advocates and consider alternative approaches if necessary.
Another commenter encouraged us to monitor the use of the care
management codes and any related feedback regarding the financial
sustainability of the model, and address any challenges and concerns in
future rulemaking.
Response: We agree that care management can lead to more effective
care, better health outcomes and fewer emergency department visits and
appreciate the concern raised by the commenters. As previously noted,
we will monitor data as it becomes available and consider a weighted
average if appropriate. We welcome RHCs, FQHCs, and others to
communicate to us any information regarding the appropriateness of
their care management payments as more experience is gained in
implementing these services.
Comment: One commenter recommended that in order to maintain
consistency and avoid confusion for providers, RHCs and FQHCs should
use the PFS CPT codes for care management services. Another commenter
stated that in order to avoid creating financial advantages for some
medical settings over others, coding and payment should be the same for
RHCs and FQHCs as for physicians billing under the PFS. This commenter
maintained that creating different coding and payment protocols may
lead to inequitable payments, and makes it difficult to assess
differences in payment adequacy.
Response: RHCs and FQHCs differ significantly from office or
hospital-based physician practices and have specific purposes,
characteristics, and requirements that generally do not apply to other
providers or suppliers. As
[[Page 53180]]
part of the nation's health care safety-net, RHCs and FQHCs are paid
under a different payment methodology that reflects the costs of
furnishing care in underserved rural and urban areas. We respectfully
do not agree that the difference in the payment systems may lead to
inequitable payments, but rather reflect the needs of these communities
in providing primary health care to underserved rural and urban
populations.
Comment: A commenter asked if certified EHR technology would be
required for billing G0511 when BHI services are furnished.
Response: Certified EHR technology is a requirement for CCM, but it
is not a requirement for general BHI or psychiatric CoCM services. To
bill the new G0511 code, an RHC or FQHC must meet the requirements for
either CCM (CPT 99490 or CPT 99487) or general BHI (CPT 99484). If the
requirements for CPT code 99484 are met, the code can be billed and
certified EHR technology is not required.
Comment: One commenter requested that we delay the denial date of
January 1, 2018, for claims submitted with CPT 99490.
Response: We wish to clarify that claims with CPT 99490 for
services furnished on or before December 31, 2017, will be processed
and paid. Service lines reported with CPT 99490 will be denied for
dates of service on or after January 1, 2018.
Comment: A few commenters requested additional information and
training on the use of these new codes for RHCs and FQHCs be made
available, and that CMS Connected Care Providers receive training
materials.
Response: Additional information on the new care management codes
for RHCs and FQHCs will be available on the CMS Web site for RHCs
(https://www.cms.gov/Center/Provider-Type/Rural-Health-Clinics-Center.html) and FQHCs (https://www.cms.gov/Center/Provider-Type/Federally-Qualified-Health-Centers-FQHC-Center.html). This will include
an MLN article for RHCs and FQHCs, and an update to the Medicare
Benefit Policy Manual, Chapter 13. These changes will also be presented
on the national CMS Rural Open Door Forum call, and on the Safety Net
Open Door Forum call (https://www.cms.gov/Outreach-and-Education/Outreach/OpenDoorForums/index.html). Information on becoming a CMS
Connected Care provider to help raise awareness about the benefits of
CCM services is available at https://www.cms.gov/About-CMS/Agency-Information/OMH/equity-initiatives/ccm/become-a-partner.html.
Comment: Some commenters discussed issues that were outside the
scope of the proposed rule.
Response: Comments received that are outside the scope of the
proposed rule are not addressed in this final rule.
As a result of the public comments, we are finalizing the revisions
to CCM payment for RHCs and FQHCs and establishment of requirements and
payment for general BHI and psychiatric CoCM services furnished in RHCs
and FQHCs, beginning on January 1, 2018, as proposed, except that we
are removing the requirement that the behavioral health care manager be
available to contact the patient outside of regular RHC or FQHC hours
as necessary to conduct the behavioral health care manager's duties.
4. Implementation
RHCs and FQHCs will continue to receive payment for CCM services
when CPT code 99490 is billed alone or with other payable services on
an RHC or FQHC claim for dates of service on or before December 31,
2017. Beginning on January 1, 2018, RHCs and FQHCs must use the new
General Care Management code G0511 when billing for CCM or general BHI
services, and the new psychiatric CoCM code G0512 when billing for
psychiatric CoCM services, either alone or with other payable services
on an RHC or FQHC claim. Service lines submitted using CPT 99490 code
for dates of service on or after January 1, 2018 will be denied.
Both the current RHC and FQHC payment rate for CCM, and the
proposed RHC and FQHC payment rates for General Care Management and
Psychiatric CoCM codes, are based on the PFS national non-facility
rates. The PFS rates are updated annually, and the new G codes for RHCs
and FQHCs would be updated accordingly and finalized when the PFS rates
are finalized for the year. No geographic adjustment will be applied to
the General Care Management or Psychiatric CoCM G codes. RHCs and FQHCs
are required to submit claims for care management services on an
institutional claim (electronically per the HIPAA compliant ANSI X12
837I or the Form CMS 1450, also known as the UB-04,) and are not
authorized to bill care management services separately to the PFS.
5. Regulatory Changes
As previously noted, Sec. 405.2413(a)(5) and Sec. 405.2415(a)(5)
was revised effective January 1, 2017, to state that services and
supplies furnished incident to CCM and TCM services can be furnished
under general supervision of an RHC or FQHC practitioner, consistent
with Sec. 410.26(b)(5), which allows CCM and TCM services and supplies
to be furnished by clinical staff under general supervision when billed
under the PFS. Sections 405.2413(a)(5) and 405.2415(a)(5) are now
revised to state that services and supplies incident to the services of
a physician, NP, PA, or CNM are furnished under the direct supervision
of a physician, NP, PA, or CNM, except for TCM, General Care
Management, and Psychiatric CoCM services, which can be furnished under
general supervision of a physician, NP, PA, or CNM when these services
or supplies are furnished by auxiliary personnel, as defined in Sec.
410.26(a)(1).
B. Part B Drug Payment: Infusion Drugs Furnished Through an Item of
Durable Medical Equipment (DME)
Section 303(c) of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) (Pub. L. 108-173, enacted on December
8, 2003) revised the payment methodology for most Medicare-covered Part
B drugs and biologicals by adding section 1847A to the Act, which
established a new average sales price (ASP) drug payment methodology
beginning January 1, 2005. Section 303(b) of the MMA specified payments
for certain drugs using methodologies other than the ASP pricing
methodology. Specifically, section 303(b) of the MMA added section
1842(o)(1)(D)(i) of the Act that required that an infusion drug
furnished through an item of DME covered under section 1861(n) of the
Act be paid 95 percent of the average wholesale price (AWP) for that
drug in effect on October 1, 2003.
Section 5004(a) of the 21st Century Cures Act (Cures Act) (Pub. L.
114-255, enacted on December 13, 2016) revised sections 1842(o)(1)(C)
and (D) of the Act, changing the payment methodology for DME infusion
drugs from being based on AWP to the methodologies in sections 1847,
1847A, 1847B, or 1881(b)(13) of the Act, as the case may be for the
drug or biological. To implement the pricing changes required by
section 5004(a) of Cures Act, which modifies the payment for DME
infusion drugs to the amount under section 1847A of the Act (ASP drug
payment methodology), by the statutorily mandated effective date of
January 1, 2017, we incorporated the ASP-based infusion drug payment
amounts into the January 2017 quarterly ASP drug pricing files and
instructed claims processing contractors to use the updated payment
limits for DME infusion drugs.
To conform regulations with the new payment requirements in section
[[Page 53181]]
5004(a) of the Cures Act as they pertain to section 1847A of the Act,
we proposed revising Sec. 414.904(e)(2). Currently, this describes an
exception to ASP-based payments and requires pricing DME infusion drugs
at 95 percent of the 2003 AWP. Consistent with section 5004(a) of the
Cures Act, the proposed revision limits the exception to infusion drugs
furnished before January 1, 2017. In addition, we proposed at Sec.
414.904(e)(2) to delete the phrase ``and is not updated in 2006.'' We
believe this language is not relevant since the statutory language
required that the pricing of DME infusion drugs be based on the October
2003 AWP. Therefore, there was no update for pricing DME infusion drugs
in 2006, and the proposed revision will serve to simplify the language.
Effective January 1, 2017, payment limits for these drugs are
determined under section 1847A of the Act.
Comment: We received one comment in which the commenter expressed
concern that immune-compromised beneficiaries will experience access
issues due to the reduction in payment for certain life-saving
therapies that are paid for under Medicare Part B and administered via
DME.
Response: We appreciate the commenters concern about access to
infusion drugs furnished through an item of covered DME. Section
5004(a) of the 21st Century Cures Act requires the change in the
payment methodology to the ASP methodology for these drugs effective
January 1, 2017. This provision of the Act does not provide us with the
flexibility to alter the payment methodology, implementation date or to
select the drugs or patient populations that will be affected by the
change.
After consideration of the public comment received, we are
finalizing our proposal to revise Sec. 414.904(e)(2) to conform with
the statutory payment requirements of section 5004(a) of the Cures Act.
We are also finalizing our proposal to revise Sec. 414.904(e)(2) to
delete the phrase ``and is not updated in 2006.''
C. Solicitation of Public Comments on Initial Data Collection and
Reporting Periods for Clinical Laboratory Fee Schedule
1. Background on Medicare Clinical Diagnostic Laboratory Tests Payment
System Final Rule
In the June 23, 2016 Federal Register (81 FR 41036) we issued a
final rule entitled, ``Medicare Program; Medicare Clinical Diagnostic
Laboratory Tests Payment System,'' to implement the requirements of
section 1834A of the Act, which requires extensive revisions to the
Medicare payment, coding, and coverage for clinical diagnostic
laboratory tests (CDLTs) paid under the Clinical Laboratory Fee
Schedule (CLFS).
Under the CLFS final rule, reporting entities are required to
report to us certain applicable information for their component
applicable laboratories. The applicable information includes, for each
CDLT furnished during a data collection period, the specific HCPCS code
associated with the test, each private payor rate for which final
payment has been made, and the associated volume of tests performed
corresponding to each private payor rate. In general, the payment
amount for a test on the CLFS furnished on or after January 1, 2018,
will be equal to the weighted median of private payor rates determined
for the test, based on the applicable information that is collected
during a data collection period and reported to us during a data
reporting period.
In the CLFS final rule, we established a data collection period
that is the 6 months from January 1 through June 30 during which
applicable information is collected and that precedes the data
collection period. We established a data reporting period that is the
3-month period, January 1 through March 31, during which a reporting
entity reports applicable information to us and that follows the
preceding data collection period. The first data collection period was
January 1, 2016 through June 30, 2016. The first data reporting period
was January 1, 2017 through March 31, 2017. This 6-month data
collection period and 3-month data reporting period schedule will be
repeated every 3 years for CDLTs that are not advanced diagnostic
laboratory tests (ADLTs), and every year for ADLTS that are not new
ADLTs.
For the first data reporting period, industry feedback suggested
that many reporting entities would not be able to submit a complete set
of applicable information to us by the March 31, 2017 deadline, and
that entities required additional time to review collected data,
address any issues identified during such review, and compile the data
into our required reporting format. As a result, on March 30, 2017, we
announced that we would exercise enforcement discretion until May 30,
2017, with respect to the data reporting period for reporting
applicable information under the Medicare CLFS and the application of
the Secretary's potential assessment of civil monetary penalties for
failure to report applicable information.\1\ The enforcement discretion
applied to entities that were subject to the data reporting
requirements finalized in the CLFS final rule (81 FR 41036). We noted
in the announcement that the 60-day enforcement discretion period was
the maximum amount of time we could permit to still have sufficient
time to calculate the CLFS payment rates scheduled to go into effect on
January 1, 2018.
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\1\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/2017-March-Announcement.pdf.
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The announcement stated that the enforcement discretion period
would not prevent reporting entities prepared to report applicable
information from doing so before May 30, 2017. We explained in the
announcement that we were committed to the successful implementation of
the new private payor rate-based CLFS and looked forward to working
with the laboratory industry to ensure accurate payment rates. In
recent months, we analyzed the applicable information we received, held
our Annual Laboratory Public Meeting, met with the Advisory Panel for
Clinical Diagnostic Laboratory tests twice, and posted preliminary CLFS
payment rates for calendar year 2018.\2\
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\2\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings.html.
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2. Solicitation of Public Comments on Medicare Clinical Diagnostic
Laboratory Tests Payment System Initial Data Collection and Reporting
Periods: Summary of Public Comments
In the proposed rule, we solicited public comments from applicable
laboratories and reporting entities to better understand the applicable
laboratories' experiences with the data reporting, data collection, and
other compliance requirements for the first data collection and
reporting periods. Specifically, we sought public comment on the
following questions:
Was the CMS data reporting system easy to use? Please
describe your overall experience with navigating the CMS data reporting
system. For example, describe the aspects of the CMS data reporting
system that worked well for your reporting entity and/or any problems
the reporting entity experienced with submitting applicable information
to us.
Did the applicable laboratory (or its reporting entity)
request and receive assistance from our Help Desk regarding the CMS
data reporting system? Please describe your experience with receiving
assistance.
[[Page 53182]]
Did the applicable laboratory (or its reporting entity)
request and receive assistance from the CMS CLFS Inquiries Mailbox
regarding policy questions? Please describe your experience with
receiving assistance.
Did the applicable laboratory (or its reporting entity)
use the subregulatory guidance on data reporting provided on the CMS
CLFS Web site? \3\ If so, was the information presented useful?
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\3\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/PAMA-Regulations.html.
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Was the information that the applicable laboratory was
required to report readily available in the applicable laboratory's
record systems?
Did the reporting entity have a manual, automated, or
semi-automated remittance process for data reporting?
If the reporting entity used a manual or semi-automated
remittance process for data reporting, what percentage of the process
was manual?
How much time (hours) was required to assemble and report
applicable information to CMS?
Is there any other information that will inform us
regarding the reporting, recordkeeping, and other compliance
requirements from the first data collection and reporting periods?
We stated in the proposed rule that we were soliciting comments to
better understand applicable laboratories' experiences with the data
reporting, data collection, and other compliance requirements for the
first data collection and reporting periods under the new private payor
rate-based CLFS. We believed industry feedback on these issues would
help inform us regarding potential refinements to the private payor
rate-based CLFS for future data collection and reporting periods. A
summary of the public comments we received on our comment solicitation,
and our response to those comments, appears below.
Comment: In response to our solicitation, we received approximately
40 comments from individuals, health care providers, corporations,
government agencies, and major laboratory organizations. Commenters
expressed that the CMS Help Desk for the data reporting system and the
subregulatory guidance on the CMS CLFS Web site were particularly
helpful. Some commenters mentioned that using the data reporting system
was challenging at first but became easier to navigate with more
experience. One commenter stated that its laboratory organization
incurred significant additional costs in collecting and reporting
applicable information due to its large number of manual remittances.
In addition, commenters provided the following specific
recommendations:
Improve the accessibility of the CMS data reporting
system, for example, by removing certain security measures.
A few commenters indicated that it was administratively
burdensome for the reporting entity, that is the Taxpayer
Identification Number (TIN) level entity, to report applicable
information individually for each of its component applicable
laboratories. As an alternative, they suggested that we allow the
reporting entity to aggregate applicable information for its components
that are applicable laboratories, and enter the aggregated applicable
information in the designated column on the CMS data reporting
template.
Change the proportion of data that applicable laboratories
are required to report; for example, allow applicable laboratories to
report 75 to 80 percent, rather than 100 percent, of their applicable
information.
Change the requirement that applicable laboratories must
report data from claims that require manual remittance processes.
Streamline the identification of user formatting errors
and permit real-time file edits in the CMS data reporting system.
Define terms used in the data reporting system; for
example, a few commenters requested CMS provide a definition for the
term ``CMS Certification Number (CCN)''.
Most of the comments received were out of scope because they did
not address experiences with the initial data collection and reporting
periods. For example, some commenters recommended that CMS delay
implementation of the new private payor rate-based CLFS payment system.
A few commenters recommended that we redefine the term ``applicable
laboratory'' to include hospitals, specifically to ensure hospital
outreach laboratory data is included in the calculation of the new CLFS
rates.
Response: We thank the commenters for their feedback and will
consider the comments for potential future rulemaking or publication of
subregulatory guidance pertaining to the CLFS data collection and
reporting periods. No CLFS data collection or reporting changes are
being proposed or finalized within this final rule. We note that a
hospital outreach laboratory, that is, a hospital based laboratory that
furnishes laboratory tests to patients other than inpatients or
outpatients of the hospital, could be an applicable laboratory if it
meets the definition of an applicable laboratory in 42 CFR 414.502.
D. Payment for Biosimilar Biological Products Under Section 1847A of
the Act
In the CY 2016 Physician Fee Schedule (PFS) final rule with comment
period, we finalized a proposal to amend the regulation text at Sec.
414.904(j) to make clear that the payment amount for a biosimilar
biological product is based on the ASP of all National Drug Codes
(NDCs) assigned to the biosimilar biological products included within
the same billing and payment code (80 FR 71096 through 71101). In
general, this means that products that rely on a common reference
product's biologics license application (that is, FDA's previous
finding of safety, purity, and potency for the common reference
product) are grouped into the same payment calculation for determining
a single ASP payment limit and that a single HCPCS code is used for
such biosimilar products. The regulation went into effect on January 1,
2016.
The comments received on the 2016 PFS proposed rule indicated that
stakeholders had varying opinions about Medicare payment for biosimilar
biological products under Part B. The commenters included individuals,
pharmaceutical manufacturers, patient advocate groups, providers,
insurers, and members of Congress. A number of commenters opposed a
single payment amount for all biosimilars that rely on FDA's finding of
safety, purity, and potency for a common reference product. Most of
these commenters believed that the proposed regulation would decrease
incentives for biosimilar development and that grouping payment for
biosimilar biological products is inconsistent with the statute. Some
commenters also expressed concerns that prescribers' choices will be
limited, that tracking or pharmacovigilance activities will be
impaired, and that innovation and product development will be harmed,
leading to market consolidation and increased costs for biosimilar
biological products. Many commenters who opposed this policy suggested
that we determine a payment amount for each biosimilar biological
product. These stakeholders have expressed concerns that the finalized
policy restricts and threatens the viability of their business models
and expressed support for a new solution. Some of these stakeholders
believed that determining a payment for each biosimilar product by
using individual HCPCS codes, would drive and reward innovators,
producing the potential cost savings of at least 10-15
[[Page 53183]]
percent compared to the reference biologic ASP necessary for biosimilar
products to compete with the reference biological.
However, some commenters supported our proposed regulation, stating
that the potential marketplace for biosimilar biological products is
large and it is less risky than the marketplace for reference
biologicals. Commenters also expressed concern that separate payment
for each biosimilar biological product would result in less competition
among manufacturers, which in turn could lead to higher payment amounts
for Medicare and beneficiaries. Some commenters stated that separate
billing codes could be perceived as a type of price protection and
could artificially increase prices for biosimilars. Commenters who
supported the proposed regulation suggested that we remain mindful of
our policy as the biosimilar biological product marketplace evolves.
Several commenters requested that policy decisions be delayed while
issues such as naming conventions and interchangeability standards are
finalized by the FDA.
In 2015, biological products accounted for the majority (65
percent) of part B spending, which totaled $26 billion including
Medicare and beneficiary payments (MedPAC Report to Congress June 2017,
page 37). As CMS expected, since the regulation was finalized in 2015,
the biosimilar product marketplace has continued to grow, and four
biosimilar biological products that are paid under Part B have been
licensed, including one product approved in 2017 that is sharing a
HCPCS code with another previously licensed biosimilar biological
product. Based on the number of biosimilar biological products that are
reported to be nearing approval and the approvals made over that past 2
years, we anticipate that several more biosimilar biological products
will be licensed for use in the United States during the next year and
that during the following years, the marketplace will continue to grow
steadily, provided that the approved products are marketed without
delay. We also anticipate that biological products will continue to be
heavily utilized in Part B. At the same time, we are aware of concerns
that current Medicare policy may discourage development of new
biosimilars and other innovation in this area potentially resulting in
higher costs over time due to a lack of competition in the market
place.
In the 2016 PFS final rule, we stated that it is desirable to have
fair reimbursement in a healthy marketplace that encourages product
development (80 FR 71101). CMS seeks to promote innovation to provide
more options to patients and physicians, and competition to drive
prices down, recognizing that even though these two goals may be
difficult to achieve concurrently, to delink them would be
counterproductive.
Although we believe that the United States biosimilar biological
product marketplace is still in an early phase (because only a few
products are on the market), we are interested in assessing the effects
of Medicare payment policy on this important portion of the Part B drug
marketplace at this time, particularly for fostering a robust, and
competitive marketplace and encouraging the innovation that is
necessary to bring more of these products to the marketplace. It is
essential to take a measured approach that considers all options given
the significant federal spending by Medicare on Part B drugs, the
effect of payment policies on program sustainability for taxpayers,
health care affordability and access for beneficiaries, and the
considerable investment the biosimilar industry reports to be making in
the nascent market (the development cost for a biosimilar product is
reported by commenters to be approximately $100-200 million). Failure
to consider the available options could potentially restrict innovation
in the marketplace, increase costs to the American taxpayer, and limit
treatment options. With that in mind, it is CMS's goal to further
evaluate our policies to be sure they allow for market forces to
provide a robust and comprehensive selection of choices for providers
and patients at a fair price. Additionally, we are interested in better
understanding if and how the differences in biological products and
their current regulatory environment should be reflected in Medicare
payment policy for biosimilars, particularly as it relates to
biosimilars that are licensed for fewer than all indications for which
the reference product is licensed or situations where different
biosimilars may be licensed for different subsets of indications for
which the reference product is licensed.
Thus, in the CY 2018 PFS proposed rule we requested comments
regarding our Medicare Part B biosimilar biological product payment
policy. This comment solicitation sought new or updated information on
the effects of the current biosimilar payment policy that is based on
experience with the United States marketplace. We stated that we were
particularly interested in obtaining material, such as market analyses
or research articles that provide data and insight into the current
economics of the biosimilar market place. This includes patient, plan,
and manufacturer data both domestic and, where applicable, from
European markets that may be more established than, and provide insight
for, the current United States market.
We also sought data to demonstrate how individual HCPCS codes could
impact the biosimilar market, including innovation, the number of
biosimilar products introduced to the market, patient access, and drug
spending. Finally, we also sought comment regarding other novel payment
policies that would foster competition, increase access, and drive cost
savings in the biological product marketplace. These novel options may
include legislation, demonstrations, and administrative options. The
comment solicitation did not include a proposal to change the existing
payment policy.
The following is a summary of the public comments received
regarding the effect of payment policies on competition, access, and
cost savings in the biological product marketplace and our responses on
this issue. We received more than 200 comments in response to the
solicitation. In general, comments were very similar to those received
during the CY 2016 PFS rulemaking period.
Comment: Most commenters opposed the current Medicare policy. These
commenters believe that the policy will impair access to biosimilars,
and could potentially limit the introduction of biosimilars to the US
market and would fail to maximize competition and savings. Some
provided updated information to support the position that greater
savings will result from the use of unique codes for each biosimilar.
Some commenters also believed that CMS should change its policy
effective January 1, 2018.
Commenters who agreed with the current Medicare policy believed
that grouping biosimilars would provide savings for beneficiaries and
for the trust fund through increased competition. These commenters
believe that separate billing codes do not foster price competition.
The commenters pointed out that ASP-based payments for groups of
potentially competing Part B drugs and biologicals remained the same or
increased between 2012 and 2017. The commenters also pointed out that
the use of separate billing codes would likely lead to high
introductory prices. These commenters noted that Part B has already
experienced a situation where the initial, WAC-based
[[Page 53184]]
payment amount for a biosimilar of infliximab exceeded the ASP-based
payment for its reference product by about 20 percent. Also, commenters
contended that the size of the United States biological market and
associated revenue would provide an incentive for manufacturers to
continue to introduce products in the US (even if biosimilars continued
to be grouped together). Finally, some commenters believed that making
a policy change at this time was not advisable because the United
States marketplace had not changed significantly since 2016.
Response: We appreciate all the commenters' input, and we will
discuss specific topics from the comment solicitation in the comment/
response sections below. We considered these comments as we evaluated
our current policy and considered changes to it.
Comment: Many commenters discussed the differences between
biosimilar biological products, such as the complexity of biological
molecules and how the manufacturing processes that are necessary to
produce them create small differences between the products. The
commenters noted that biosimilars are similar, but not identical, to
their reference products, and that as a result of potentially subtle
differences, they may have different therapeutic and adverse effects on
patients, requiring clinical as well as payment distinctions between
the products. These commenters believed that Medicare payment policy
that treats biosimilars like generic drugs by grouping them for payment
would lead to prescribing choices based on cost rather than clinical
considerations.
Several commenters also discussed issues related to the differences
between products in more detail, as well as the interchangeability of
biosimilar biological products. Although none of the currently
available biosimilars are approved as interchangeable (and finalized
FDA guidance on the subject is not yet available), some commenters
believed that grouping products for payment could be understood by
clinicians and patients that the products could be interchangeable.
Some commenters also pointed out that the current biosimilar approval
process does not compare biosimilar biological products to each other,
rather, only similarity to a reference product is established and the
licensing of a biological product under the biosimilar pathway does not
mean that the products are interchangeable. Also, commenters noted that
biosimilar biological products may be approved for fewer indications
than the reference product and that the approved indications within a
group of biosimilar biological products with the same reference product
may vary. Some commenters believed that blended payment for biosimilar
biological products that do not have all the same indications could
lead to off-label use.
Many commenters believed that differences between biosimilar
biological products that share a common reference product exist and
stated that such distinctions, which may affect the clinical use of a
product on specific patients, support the need for separate coding and
payment for biosimilars under Medicare Part B. Some commenters also
associated these concerns with concerns about payment for biosimilar
biological products.
Several comments discussed the relationship between costs, prices,
and competition in the biologicals and biosimilars market, as follows.
Because these products are likely to be expensive and may have
different acquisition costs, blended payment was perceived by many
commenters as a significant financial risk to the provider because the
provider could not be highly certain that the products that would be
the best choice for a patient would also be likely to be paid above
acquisition cost. These commenters believed that separate codes would
lead to more certainty about payment amounts for biosimilar biological
products. Some commenters were concerned that ``race to the bottom''
pricing competition would result from shared codes and lead to prices
that could not sustain educational efforts and other activities
associated with marketing new and complex biological products,
ultimately resulting in manufacturers leaving the United States
marketplace. The commenters also noted that the development costs for
these products and their manufacturing facilities are estimated to be
in the hundreds of millions of dollars.
Commenters also expressed concern about the lack of competition
between biosimilars and their reference product. Some commenters who
disagreed with CMS's current approach of grouping biosimilar biological
products for payment believed that separate codes would lead to
opportunities for greater and more direct competition between the
reference product and its biosimilar versions.
Other commenters who agreed with current Medicare policy, suggested
that payment for biosimilars should be based on grouping the reference
product with its corresponding biosimilars in the same billing and
payment code and suggested that legislative authority for such a change
should be sought by CMS. These commenters opined that combining
reference products and corresponding biosimilar biological products
into the same billing and payment code would maximize competition for
items with similar effects. In the absence of authority to expand
grouped payment to include the reference product, most of these
commenters agreed with the current approach of grouping biosimilar
biological products of the same reference product into the same billing
and payment code.
Response: We appreciate the commenters' wide range of concerns
about the differences between biosimilar biological products and how
payment approaches may influence clinical decisions.
Many of these concerns were brought up in comments on biosimilars
made in response to the CY 2016 PFS final rule with comment period. We
discussed these issues, including differences between small molecule
drugs and biologicals (including biosimilars), generic drugs, and
interchangeability in the 2016 final rule. However, as we have further
considered the Part B biosimilar biological payment policy and this
year's comments, we have become increasingly concerned about the
relationship between cost, prices and competition; specifically, many
commenters' continued unease regarding the effects of our payment
policy on patient and provider choices, as well as the biosimilar
marketplace. We have also considered how the payment policy could
affect market entry of new biosimilar manufacturers. If payment amounts
limit manufacturers' willingness to invest in the development of new
biosimilars, it could in the long term, decrease the number of
biosimilar biological products that are available to prescribe and thus
impair price competition. Given that the United States' biosimilar
biological product marketplace is still relatively new, we believe that
it is important to maintain a payment policy innovation as well as
reasonable pricing for consumers.
We agree that current statutory authority does not permit the
inclusion of the reference product in a payment determination
calculation for biosimilar biological products paid under Medicare Part
B.
Comment: Some commenters did not believe that separate coding for
each biosimilar product would lead to greater competition or savings.
These commenters noted that ASP-based payment amounts for biological
drugs, even those with other comparable products on the market,
continue to
[[Page 53185]]
increase. Also, they provided specific examples where the payment
amount for reference products filgrastim and infliximab, which are
currently paid under Part B (and are coded and paid separately from
corresponding biosimilar products) have not decreased; these commenters
expressed concern about a potential lack of competition within the Part
B marketplace. Some of these commenters also expressed concern about
the United States experience with high launch prices for biosimilars,
particularly one situation where the Part B payment amount for a
biosimilar significantly exceeded the payment amount for a reference
product. The commenters pointed out that in situations where each
product has a unique code, high launch prices, particularly while a
product is paid using Wholesale Acquisition Cost (WAC), would lead to
higher costs for Medicare and beneficiaries. One commenter also stated
that combining payment for biosimilar products is consistent with the
concept of similar payment for similar services.
Response: We note that section 1847A(c)(4) of the Act authorizes
WAC based payment during the first quarter of sales and this subject
has been discussed in rulemaking previously (75 FR 73465). In most
cases WAC exceeds ASP. However, the duration of a WAC based payment
amount is limited, and generally, once a full quarter of ASP data is
available, payments made under section 1847A are based on ASP.
Comment: Several commenters provided materials that were previously
submitted with comments on the CY 2016 PFS proposed rule, in response
to our solicitation of new or updated information on the effects of our
biosimilars payment policy on the United States marketplace.
One commenter also provided a revised industry estimate from the
Biosimilars Forum that projected $50 billion in savings to the Medicare
program over 10 years under the existing policy and an additional $15
billion in savings over 10 years if separate codes were used. This
estimate, which was referenced by a number of other commenters, assumes
higher uptake of biosimilars (up to 65 percent at 10 years, compared to
35 percent with current policy) if separate codes are implemented.
Commenters stated that they believe the separate coding approach would
create competition and lower prices for the long term. The main reasons
for this were: Increased physician confidence (mainly associated with
certainty about the payment amount), a number of manufacturers and
products in the marketplace, and resources (from the manufacturers)
that would encourage uptake.
Response: We thank commenters for the updated estimates.
Comment: Several commenters also discussed the European biosimilar
product market. Commenters who support current Medicare policy pointed
out that the European market as a whole has grown and includes nearly
30 biosimilar biological products. Another commenter referenced a
report on the European biosimilar market (The Impact of Biosimilar
Competition in Europe. QuintilesIMS. May 2017) and described the report
as indicating that competition reduces prices, and that government
policies could influence both manufacturer participation in a market as
well as uptake of products. The report and other commenters who do not
support current Medicare policy pointed out a specific European example
from Austria where a tiered pricing policy treats biosimilar biological
products exactly as generic drugs. A significant payment reduction
associated with this policy is thought to have contributed to low
biosimilar biological product utilization and limited access in this
country.
Response: We appreciate the examples of approaches used to pay for
biosimilars in Europe. In general, we believe that the European
examples provided by commenters help confirm that savings can be
expected in the United States marketplace with a variety of policy
approaches because payments for biosimilar products used in Europe are
determined in a several ways. In other words, several payment
approaches for biosimilars have yielded savings. We also agree that the
introduction of new products and savings may be influenced by a
government's payment policies. We note that payment methodologies for
drugs and biologicals in many European countries differ, sometimes
significantly, from payment methodologies for drugs and biologicals in
the United States. For example, a number of European countries utilize
a single payer system and some have the authority to set prices, so
some of these examples may not provide information that is fully
applicable to the United States market. For example, the description of
Austria's payment policy for biosimilar biological products is not
similar to our pricing policy for several reasons. First, Austria uses
a single payer system that we understand to include mandatory payment
reductions in certain circumstances. We do not use a tiered pricing
strategy in Part B and, under the payment methodology in section 1847A
of the Act, we cannot mandate 40 to 50 percent reductions in payment
for biosimilar biological products by deeming them generic drugs as
Austria has done. We believe that many commenters continue to
misunderstand our position on the relationship between biosimilar
biological products and generic drugs, that is, we distinguish between
the two. As we noted in the CY 2016 PFS final rule with comment period,
our payment policy does not address whether a biosimilar is completely
or partially analogous to its reference product as a clinical matter
(80 FR 71100). We have communicated that we appreciated the complexity
of these products and the potential differences in the clinical
utilization of biosimilar biological products when they are being used
to treat individual patients. In summary, we believe that most of the
examples provided by commenters include helpful information to consider
as the United States marketplace develops.
Comment: We also sought comment regarding other novel payment
policies, legislation, demonstrations, and administrative options that
would foster competition, increase access, and drive cost savings in
the biological product marketplace.
As discussed earlier in this section, several commenters discussed
code consolidation where reference and corresponding biosimilar
products would be included in a shared code. Commenters also suggested
that value based purchasing models, including outcomes-based pricing
and pricing based on negotiations between a vendor and manufacturers,
be considered for biosimilar biological products (as well as other
drugs). One commenter also stated that paying differently for
biosimilars and interchangeable products may create incentives for
growth in the marketplace. One manufacturer suggested that the ASP add
on percentage could be increased to the 15-20 percent range to
encourage uptake.
We also received comments that encouraged consistency between Part
B, Part D and Medicaid, and comments that encouraged streamlining and
simplification of price reporting, as well as comments on HCPCS coding
schedules and deadlines, the use of NDCs on claims, pharmacy
substitution activities, coverage, and the FDA naming conventions for
biosimilars.
Response: We appreciate these comments and we plan to consider them
for future policy decisions. Regarding the ASP add-on percentage for
biosimilar products, we note that the statute requires the ASP add-on
to be 6 percent of the reference product. We
[[Page 53186]]
note that some of these issues are generally outside the scope of Part
B payment policy and that statutory requirements may also constrain
flexibility to modify or conform policies.
Comment: Some commenters also noted that the use of a modifier to
track the manufacturer of a biosimilar biological product was perceived
as burdensome and suggested that unique codes were more desirable and
more convenient for tracking. However, several commenters stated that
the use of modifiers is an acceptable method of tracking biosimilars.
Both groups appeared to agree that tracking the use of these new and
complex products was necessary.
Response: We agree that tracking the use of these new and complex
products is important. We believe that either method, code and modifier
combinations or unique codes, can be used for this purpose. We plan to
continue to monitor Part B biosimilar payment and utilization,
particularly as they relate to access, including the number of products
available to beneficiaries with Part B and cost savings associated with
Medicare and beneficiary payments.
Comment: Many commenters requested that a change in policy be made
as soon as possible so that manufacturers would be incentivized to
enter the United States marketplace as soon as possible. Several
commenters, including most who supported continuing the current policy
and others who did not explicitly support either changing or not
changing policy at this time, believed that there is insufficient
experience with the United States marketplace to warrant making a
change in policy at this time, but they suggested that CMS continue to
examine its policy, and that changes should consider effects on
patients, providers and manufacturers.
Response: We appreciate the broad range of possibilities that
commenters have provided during this rulemaking cycle. We agree that it
is important to consider and effect policy changes early, as this
portion of the drug marketplace develops, in order to support a robust
marketplace that provides choices for providers and patients while
maximizing savings.
Comment: Several commenters urged CMS to change the regulation text
to indicate that separate payment for each biosimilar biological
product is required, and to do so in this final rule. Some commenters
believe that there is sufficient legal basis to do so despite the fact
that CMS did not make a proposal.
Response: We have not proposed to make a regulation change and we
will not be doing so in this final rule. We continue to believe, as we
stated in the CY2016 PFS final rule with comment period, that the
existing regulation text provides flexibility to accommodate policy
changes in a new and evolving environment. Specifically, we stated in
the CY 2016 PFS rule that current regulation text at Sec. 414.904(j)
would not preclude us from separating some, or all, of a group of
biosimilars for payment (and the creation of one or more separate HCPCS
codes) should a program need to do so arise (80 FR 71098). As we have
stated earlier in this rule, we are particularly concerned about the
commenters' continuing unease regarding the effects of our payment
policy on patient and provider choices, and the interaction between the
payment policy, choice, and the marketplace. In an effort to support a
more competitive marketplace and greater choice and value for
beneficiaries, CMS is taking immediate action on this issue. We will
discuss our reasons further in the paragraphs below.
We appreciate the many responses that we received to our comment
solicitation. Comments received about the issue of grouping or
separating payment for biosimilars of the same reference product were
sharply divided, and information provided as support for a given
position was also subject to interpretation. For example, a commenter
who is opposed to the current policy cited a report (Scott Morton F,
Boller LT. Enabling Competition in Pharmaceutical Markets. Hutchins
Center. May 2017as evidence that robust competition could reduce costs
in the long-term; however, another portion of the report supported
MedPAC's June 2017 recommendation to pay biosimilars and reference
products under the same code (which CMS does not have the authority to
do). We are acknowledging that opinions on the issue of how Part B
should pay for biosimilar biological products vary, however, as
discussed below, we believe that the solution discussed in the
paragraphs below is superior to existing policy.
As we stated previously, we seek to promote innovation, to provide
more options to patients and physicians, and to encourage competition
to drive prices down. We also stated that our goal for the comment
solicitation was to further evaluate our policies to be sure they allow
for market forces to provide a robust and comprehensive selection of
choices for patients at a fair price. Based on the review of the
comments that are summarized above, we are persuaded that changing the
Part B biosimilar payment policy to provide for the separate coding and
payment for products approved under each individual abbreviated
application, rather than grouping all biosimilars with a common
reference product into codes, will meet the stated goal. We believe
that this policy change will encourage greater manufacturer
participation in the marketplace and the introduction of more
biosimilar products, thus creating a stable and robust market, driving
competition and decreasing uncertainty about access and payment. First,
as we have discussed, we anticipate that this policy change will
provide physicians with greater certainty about biosimilar payment. We
are persuaded that, in turn, this will affect utilization of these
products, creating more demand that would help increase competition
(compared to the policy that is currently in place). As a result of the
policy change we anticipate greater access to biosimilar biological
products and we anticipate that more price competition between more
products will occur because there will be more products available. The
change in policy could lead to additional savings for Medicare and its
beneficiaries over the long-term by increasing the utilization of
products that are less expensive than reference biologicals. Further,
carrying out this policy change as early as possible, rather than
waiting, would maximize the benefits described in this paragraph and
would bring more certainty to the new and developing marketplace
promptly.
In summary, we are persuaded that that there is a program need for
assigning Part B biosimilar biological products into separate HCPCS
codes, specifically that this policy change will address concerns about
a stronger marketplace, access to these drugs in the United States
marketplace, provider and patient choice and competition. We also
believe that the change in policy will encourage innovation needed to
bring more products to the market. We remind readers that our preamble
language in the CY 2016 PFS rule with comment period (80 FR 71096)
indicated that policy changes could be forthcoming (80 FR 71098).
Thus, in this final rule, we are finalizing the policy to
separately code and pay for biological biosimilar products under
Medicare Part B; we are not changing regulation text at Sec.
414.904(j). Effective January 1, 2018, newly approved biosimilar
biological products with a common reference product will no longer be
grouped into the same HCPCS code. We will issue detailed guidance on
coding, including
[[Page 53187]]
instructions for new codes for biosimilars that are currently grouped
into a common payment code and the use of modifiers. Completion of
these changes, which will require changes to the claims processing
systems, is planned to occur as soon as feasible, but should not be
expected to be complete by January 1, 2018. We anticipate that this
will be done by mid-2018 and we plan to issue instructions using
subregulatory means, such as change requests/transmittals to
contractors and the ASP Web site.
As suggested by commenters who supported both policy approaches, we
plan to continue to monitor Part B biosimilar payment and utilization,
particularly as they relate to access, including the number of products
available to beneficiaries with Part B and cost savings associated with
Medicare and beneficiary payments. We also appreciate the comments on
novel payment policies that would foster competition, increase access,
and drive cost savings in the biological product marketplace.
E. Appropriate Use Criteria for Advanced Diagnostic Imaging Services
Section 218(b) of the Protecting Access to Medicare Act (PAMA)
amended Title XVIII of the Act to add section 1834(q) of the Act
directing us to establish a program to promote the use of appropriate
use criteria (AUC) for advanced diagnostic imaging services. The CY
2016 PFS final rule with comment period addressed the initial component
of the new Medicare AUC program, specifying applicable AUC. In that
rule (80 FR 70886), we established an evidence-based process and
transparency requirements for the development of AUC, defined provider-
led entities (PLEs) and established the process by which PLEs may
become qualified to develop, modify or endorse AUC. The first list of
qualified PLEs was posted on the CMS Web site at the end of June 2016
at which time their AUC libraries became specified applicable AUC for
purposes of section 1834(q)(2)(A) of the Act. The CY 2017 PFS final
rule addressed the second component of this program, specification of
qualified clinical decision support mechanisms (CDSMs). In that rule
(81 FR 80170), we defined CDSM, identified the requirements CDSMs must
meet for qualification including an opportunity for preliminary
qualification for mechanisms still working toward full adherence, and
established a process by which CDSMs may become qualified. We also
defined applicable payment systems under this program, specified the
first list of priority clinical areas and identified exceptions to the
requirements that ordering professionals consult specified applicable
AUC when ordering applicable imaging services. The first list of
qualified CDSMs was posted on the CMS Web site in July 2017.
The CY 2018 PFS proposed rule proposed the start date of January 1,
2019 for the Medicare AUC program for advanced diagnostic imaging
services. It is on and after this date that ordering professionals must
consult specified applicable AUC using a qualified CDSM when ordering
applicable imaging services and furnishing professionals must report
consultation information on the Medicare claim. This rule also proposed
to modify the policy related to significant hardship exceptions and
requested public feedback on details regarding how AUC consultation
information must be included on the Medicare claim. To further this
iterative process of implementation, we also discussed briefly the
potential for alignment with other Medicare quality programs.
1. Background
AUC present information in a manner that links: A specific clinical
condition or presentation, one or more services and, an assessment of
the appropriateness of the service(s). For purposes of this program AUC
is a set or library of individual appropriate use criteria. Each
individual criterion is an evidence-based guideline for a particular
clinical scenario. Each scenario in turn starts with a patient's
presenting symptoms or condition. Evidence-based AUC for imaging can
assist clinicians in selecting the imaging study that is most likely to
improve health outcomes for patients based on their individual clinical
presentation.
AUC need to be integrated as seamlessly as possible into the
clinical workflow. CDSMs are the electronic portals through which
clinicians access the AUC during the patient workup. While CDSMs can be
standalone applications that require direct entry of patient
information, they may be more effective when they automatically
incorporate information such as specific patient characteristics,
laboratory results, and lists of co-morbid diseases from Electronic
Health Records (EHRs) and other sources. Ideally, practitioners would
interact directly with the CDSM through their primary user interface,
thus minimizing interruption to the clinical workflow.
Consistent with descriptions of clinical decision support by the
Agency for Healthcare Research and Quality (AHRQ) (http://www.ahrq.gov/professionals/prevention-chronic-care/decision/clinical/index.html),
and the Office of the National Coordinator for Health Information
Technology (ONC) (https://www.healthit.gov/policy-researchers-implementers/clinical-decision-support-cds), within health IT
applications, a CDSM is a functionality that provides persons involved
in care processes with general and person-specific information,
intelligently filtered and organized, at appropriate times, to enhance
health and health care.
2. Statutory Authority
Section 218(b) of the PAMA added a new section 1834(q) of the Act
entitled, ``Recognizing Appropriate Use Criteria for Certain Imaging
Services,'' which directs the Secretary to establish a new program to
promote the use of AUC. Section 1834(q)(4) of the Act requires ordering
professionals to consult with a qualified CDSM for applicable imaging
services furnished in an applicable setting and paid for under an
applicable payment system; and for the furnishing professional to
include on the Medicare claim information about the ordering
professional's consultation with a qualified CDSM.
3. Discussion of Statutory Requirements
There are four major components of the AUC program under section
1834(q) of the Act, and each component has its own implementation date:
(1) Establishment of AUC by November 15, 2015 (section 1834(q)(2) of
the Act); (2) identification of mechanisms for consultation with AUC by
April 1, 2016 (section 1834(q)(3) of the Act); (3) AUC consultation by
ordering professionals, and reporting on AUC consultation by furnishing
professionals by January 1, 2017 (section 1834(q)(4) of the Act); and
(4) annual identification of outlier ordering professionals for
services furnished after January 1, 2017 (section 1834(q)(5) of the
Act). We did not identify mechanisms for consultation by April 1, 2016.
Therefore, we did not require ordering professionals to consult CDSMs
or furnishing professionals to report information on the consultation
by the January 1, 2017 date.
a. Establishment of AUC
In the CY 2016 PFS final rule with comment period, we addressed the
first component of the Medicare AUC program under section 1834(q)(2) of
the Act--the requirements and process for establishment and
specification of applicable AUC, along with relevant aspects of the
definitions under section 1834(q)(1) of the Act. This included
[[Page 53188]]
defining the term PLE and finalizing requirements for the rigorous,
evidence-based process by which a PLE would develop AUC, upon which
qualification is based, as provided in section 1834(q)(2)(B) of the Act
and in the CY 2016 PFS final rule with comment period. Using this
process, once a PLE is qualified by CMS, the AUC that are developed,
modified or endorsed by the qualified PLE are considered to be
specified applicable AUC under section 1834(q)(2)(A) of the Act. We
defined the term PLE to include national professional medical
societies, health systems, hospitals, clinical practices and
collaborations of such entities such as the High Value Healthcare
Collaborative or the National Comprehensive Cancer Network. Qualified
PLEs may collaborate with third parties that they believe add value to
their development of AUC, provided such collaboration is transparent.
We expect qualified PLEs to have sufficient infrastructure, resources,
and the relevant experience to develop and maintain AUC according to
the rigorous, transparent, and evidence-based processes detailed in the
CY 2016 PFS final rule with comment period.
In the same rule we established a timeline and process under Sec.
414.94(c)(2) for PLEs to apply to become qualified. Consistent with
this timeline the first list of qualified PLEs was published at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/PLE.html (OMB Control
Number 0938-1288).
b. Mechanism for AUC Consultation
In the CY 2017 PFS final rule, we addressed the second major
component of the Medicare AUC program--the specification of qualified
CDSMs for use by ordering professionals for consultation with specified
applicable AUC under section 1834(q)(3) of the Act, along with relevant
aspects of the definitions under section 1834(q)(1) of the Act. This
included defining the term CDSM and finalizing functionality
requirements of mechanisms, upon which qualification is based, as
provided in section 1834(q)(3)(B) of the Act and in the CY 2017 PFS
final rule. We included an opportunity for mechanisms still working
toward full adherence to these requirements to receive preliminary
qualification during the preliminary qualification period that begins
June 30, 2017, and ends when the AUC consulting and reporting
requirements become effective. The preliminarily qualified CDSMs must
meet all requirements by that time. We defined CDSM as an interactive,
electronic tool for use by clinicians that communicates AUC information
to the user and assists them in making the most appropriate treatment
decision for a patient's specific clinical condition. Tools may be
modules within or available through certified EHR technology (as
defined in section 1848(o)(4) of the Act) or private sector mechanisms
independent from certified EHR technology or established by the
Secretary.
In the CY 2017 PFS final rule we established a timeline and process
in Sec. 414.94(g)(2) for CDSM developers to apply to have their CDSMs
qualified. Consistent with this timeline, the first list of qualified
CDSMs was published at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/CDSM.html in conjunction with this rule in July 2017 (OMB
Control Number 0938-1315).
c. AUC Consultation and Reporting
The third major component of the Medicare AUC program is in section
1834(q)(4) of the Act, Consultation with Applicable Appropriate Use
Criteria. This section establishes, beginning January 1, 2017, the
requirement for an ordering professional to consult with a qualified
CDSM when ordering an applicable imaging service that would be
furnished in an applicable setting and paid for under an applicable
payment system; and for the furnishing professional to include on the
Medicare claim information about the ordering professional's
consultation with a qualified CDSM. The statute distinguishes between
the ordering and furnishing professional, recognizing that the
professional who orders an applicable imaging service is usually not
the same professional who bills Medicare for that service when
furnished. Since a list of qualified CDSMs was not available by January
1, 2017, we did not require ordering professionals to meet the
consultation requirement by that date.
Section 1834(q)(4)(C) of the Act provides for certain exceptions to
the AUC consultation and reporting requirements including in the case
of certain emergency services, inpatient services paid under Medicare
Part A, and ordering professionals who obtain an exception due to a
significant hardship. In the CY 2017 PFS final rule, we identified the
circumstances specific to ordering professionals under which consulting
and reporting requirements are not required. These include orders for
applicable imaging services: (1) For emergency services when provided
to individuals with emergency medical conditions as defined in section
1867(e)(1) of the Act; (2) for an inpatient and for which payment is
made under Medicare Part A; and (3) by ordering professionals who are
granted a significant hardship exception to the Medicare EHR Incentive
Program payment adjustment for that year under 42 CFR 495.102(d)(4),
except for those granted such an exception under Sec.
495.102(d)(4)(iv)(C). We discuss changes to the significant hardship
exceptions later in this preamble.
Section 1834(q)(4)(D) of the Act specifies the applicable payment
systems for the AUC consultation and reporting requirements, and, in
the CY 2017 PFS final rule we defined them as: (1) The physician fee
schedule established under section 1848(b) of the Act; (2) the
prospective payment system for hospital outpatient department services
under section 1833(t) of the Act; and (3) the ambulatory surgical
center payment system under section 1833(i) of the Act.
d. Identification of Outliers
The fourth component of the Medicare AUC program is in section
1834(q)(5) of the Act, Identification of Outlier Ordering
Professionals. The identification of outlier ordering professionals
under this paragraph facilitates a prior authorization requirement for
outlier professionals beginning January 1, 2020, as specified under
section 1834(q)(6) of the Act. Given that we proposed a program start
date of January 1, 2019, we anticipate that implementation of the prior
authorization component would be delayed. We expect to discuss details
around outlier calculations and prior authorization in the CY 2019 PFS
proposed rule. However, we did finalize in the CY 2017 PFS final rule
the first list of priority clinical areas to guide identification of
outlier ordering professionals as follows:
Coronary artery disease (suspected or diagnosed).
Suspected pulmonary embolism.
Headache (traumatic and non-traumatic).
Hip pain.
Low back pain.
Shoulder pain (to include suspected rotator cuff injury).
Cancer of the lung (primary or metastatic, suspected or
diagnosed).
Cervical or neck pain.
As established in Sec. 414.94(e)(4) of our regulations, priority
clinical areas may be used in the identification of outlier ordering
professionals. By starting to identify these areas now, we believe
ordering professionals will have the opportunity to become familiar
with
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AUC within identified priority clinical areas prior to Medicare claims
for those services being part of the input for calculating outlier
ordering professionals.
We did not include proposals to expand or modify the list of
priority clinical areas in the CY 2018 PFS proposed rule.
4. Proposals for Continuing Implementation
In the CY 2018 PFS proposed rule, we proposed to amend Sec. 414.94
of our regulations, ``Appropriate Use Criteria for Certain Imaging
Services,'' to reflect the following policies.
a. Consultation by Ordering Professional and Reporting by Furnishing
Professional Timeline
We proposed that ordering professionals must consult specified
applicable AUC through qualified CDSMs for applicable imaging services
furnished in an applicable setting, paid for under an applicable
payment system and ordered on or after January 1, 2019. We proposed
this effective date for the consulting and reporting requirements to
allow time for ordering practitioners who are not already aligned with
a qualified CDSM to research and evaluate the qualified CDSMs so they
may make an informed decision. Although there will be an additional
rulemaking cycle before the consulting and reporting requirement is
effective, we are establishing the date through rulemaking this year
because we expect practitioners and other stakeholders to begin
preparing themselves to report and we want to ensure all impacted
parties have sufficient time to prepare to meet the requirements of
this program.
After proposing the timeline and process for qualification of CDSMs
in the CY 2017 PFS proposed rule (81 FR 46392), we anticipated that
furnishing professionals may begin reporting as early as January 1,
2018. However, we received comments that these timelines did not allow
enough time to address the needs of different stakeholder groups. Some
commenters requested that we delay the timeline and process to give
practitioners sufficient time to obtain a qualified CDSM. Other
commenters cited insufficient time for CDSMs to incorporate
requirements between the release of the final CDSM requirements and
January 1, 2018, and requested that we fully implement the program at a
later date. Additionally, in the CY 2017 PFS final rule (81 FR 80411)
we discussed commenters' recommendations that we develop and launch an
educational campaign, including a Town Hall meeting. Some commenters
requesting additional time suggested that, for purposes of both CDSM
vendor readiness and practitioner readiness, consulting and reporting
requirements should not go into effect for an additional 12-18 months
after the initial list of CMS-qualified CDSMs is posted.
By proposing that the consulting and reporting requirements begin
on January 1, 2019, we intended to allow needed time for education and
outreach efforts, time for practitioners and stakeholders to prepare,
and time for CDSMs to continue current strides in being more user-
friendly and less burdensome. We note that the statute required
publication of qualified CDSMs by April 1, 2016, and required AUC
consultation and reporting by January 1, 2017; therefore, our proposal
substantially lags the statutory requirements. As noted earlier and in
previous rulemaking, a delay in the statutory timeline is necessary to
maximize the opportunity for public comment and stakeholder engagement,
which is also a statutory requirement, and allow for adequate advance
notice to practitioners, beneficiaries, AUC developers, and CDSM
developers. This delay is also important to allow time to test and
ensure Medicare claims processing systems are ready to accept and
process claims that include the necessary AUC consultation information.
Failure to test our own processes could result in claims being denied
inappropriately or, conversely, being paid inappropriately.
The following is a summary of the public comments received on the
proposed effective date for consulting and reporting requirements:
Comment: Some commenters strongly supported the proposal to begin
the AUC consultation and reporting requirement in January 2019 and
further stated that additional delays beyond 2019 are not warranted.
They asserted that physicians need certainty that the AUC program will
move forward on a predictable timeline and will not be subject to
continued changes. Some commenters stated that they are prepared for
this program to begin and that others will be prepared within one year.
In contrast, other commenters do not want this AUC program implemented
in 2019 or at any point in the future. These commenters wanted the
program to be delayed indefinitely, discontinued or modified to the
extent that participation be only voluntary as opposed to mandatory.
Some of these commenters stated that the quality goals of the AUC
program are duplicative of the quality goals of the Quality Payment
Program and that the AUC program runs counter to the agency's goal of
reducing administrative burden for practitioners and providers. Some
suggested that the Quality Payment Program could serve as a less
burdensome approach to achieving the same goals. Commenters disagreed
with the premise behind the AUC consultation and reporting requirement
that the furnishing professional claim should not be paid when the
ordering professional failed to perform an AUC consultation.
Response: We recognize the interest from commenters in better
understanding our separate and distinct efforts to improve quality, and
note that such efforts are the result of the distinct statutory
requirements for the AUC program required in section 1834(q) of the Act
as added by section 218(b) of the statute and the Quality Payment
Program required in section 1848(q) of the Act as added by the Medicare
Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10).
We agree that the goals of the Quality Payment Program are consistent
with those of the AUC program. In addition, the AUC program promotes
AUC to ensure the patient gets the right test at the right time and
reduces inappropriate imaging. We are required by separate statutory
authority provisions to implement the AUC program and the Quality
Payment Program. Section 1834(q) of the Act requires AUC consultation
information to be included on the furnishing professional's claim in
order for that claim to be paid; we do not have discretion with respect
to that requirement.
Comment: There are commenters that supported the AUC program but
suggested that CMS participate in further stakeholder engagement. These
commenters suggested an advisory panel be created to identify a
reasonable program start date based on the readiness of practitioners,
facilities, EHRs and CDSMs. Commenters also recommended listening
sessions, town hall meetings and open door forums for stakeholders to
share information with CMS about minimizing burden and communicating
the state of stakeholder readiness.
Response: We agree that we would benefit from additional
stakeholder engagement. Over the coming months we will establish
opportunities for this type of interaction.
Comment: Although some commenters very clearly expressed strong,
clear positions either for or against the proposed effective date for
the AUC consultation and reporting requirements, as well as the AUC
program more generally, the majority of commenters were more nuanced in
their
[[Page 53190]]
comments and gave additional opinions regarding not only the start date
but options as to how the program should begin.
Response: We will summarize and respond to these comments in a
later section of this preamble within the relevant sections that
discuss the voluntary participation and educational and operations
testing periods we are finalizing in this rule.
Comment: Numerous commenters requested clarification regarding who
is required to perform the consultation of AUC through a qualified
CDSM. Commenters questioned whether a designee within an ordering
professional's practice could consult on behalf of the ordering
professional and whether an ordering professional could delegate
consultation authority to another individual, a third party vendor or
contracted agent. Several commenters supported this notion, noting that
state laws allow professionals to delegate to qualified individuals in
practice under the supervision of a physician the ability to assist
advanced imaging orders, and URAC states that an organization
conducting utilization review must accept information from any
reasonably reliable source that will assist in the certification
process. One commenter recommended that CMS reinforce the requirement
that the ordering professional responsible for the order must
meaningfully interact with AUC at the time of order, but allow the
market to develop compliant approaches that ensure the educational
effect of AUC is achieved. Some commenters supported delegation only to
the ordering professional's staff while other commenters opposed
allowing consultation by anyone other than the ordering professional,
which they understand as the clear requirement under section 1834(q) of
the Act and the current AUC regulations, and are concerned that other
types of individuals and stakeholders are preparing to circumvent this
requirement by performing consultations on behalf of ordering
professionals.
Response: Section 1834(q)(4)(A)(i) of the Act requires an ordering
professional to consult with a qualified CDSM. We appreciate the
varying opinions presented by stakeholders and the number of commenters
who raised these questions. We will consider developing policy to
address this issue.
Comment: Some commenters requested that we clarify how imaging
replacement orders, where the furnishing professional or radiology
technician updates or modifies an order based on new information at the
time of imaging, are handled under the AUC program. Commenters
questioned whether the furnishing professional can update the order as
necessary or if they need to consult with the ordering professional or
AUC again to generate a new determination of appropriateness. One
commenter requested that CMS provide guidance for situations where the
furnishing professional performs different or additional tests than
ordered in accordance with guidance in Medicare publication 100-02,
Chapter 15, sections 80.6.2-4. Some commenters recommended that
furnishing professionals have the flexibility to adjust exam parameters
or modify orders without consulting AUC, submit orders themselves if
they have relevant patient clinical information, and occasionally use
AUC as appropriate to demonstrate that a test was warranted.
Response: We understand that in certain situations updates or
modifications to orders for advanced diagnostic imaging services may be
warranted once the beneficiary is under the care of the furnishing
professional. As a commenter noted, the Medicare Benefit Policy Manual
(Pub. L. 100-02) addresses rules around these situations in Chapter 15,
sections 80.6.2-4. We do not believe it was the intent of section
218(b) of the PAMA to reverse these rules, and we expect furnishing
professionals and facilities to continue to adhere to them so as to
avoid additional burden, workflow interruptions and delays in medically
necessary services.
In instances when the furnishing professional must update or modify
the order for an advanced diagnostic imaging service, the AUC
consultation information provided by the ordering professional with the
original order should be reflected on the Medicare claim to demonstrate
that the requisite AUC consultation occurred. In future rulemaking, we
expect to establish a means to account for instances when the order
must be updated or modified. We anticipate addressing this issue in
rulemaking to develop policies relating to the identification of
outlier ordering professionals, and in order to inform the prior
authorization component of this program.
In response to public comments we are further delaying the
effective date for the AUC consultation and reporting requirements for
this program from January 1, 2019 as proposed to January 1, 2020. We
are also finalizing a voluntary period during which early adopters can
begin reporting limited consultation information on Medicare claims
from July 2018 through December 2019. During the voluntary period there
is no requirement for ordering professionals to consult AUC or
furnishing professionals to report information related to the
consultation. On January 1, 2020, the program will begin with an
educational and operations testing period and during this time we will
continue to pay claims whether or not they correctly include such
information. Ordering professionals must consult specified applicable
AUC through qualified CDSMs for applicable imaging services furnished
in an applicable setting, paid for under an applicable payment system
and ordered on or after January 1, 2020, and furnishing professionals
must report the AUC consultation information on the Medicare claim for
these services ordered on or after January 1, 2020.
Reporting
Consistent with section 1834(q)(4)(B) of the Act, we also proposed
that furnishing professionals report the following information on
Medicare claims for applicable imaging services, furnished in an
applicable setting, paid for under an applicable payment system as
defined in Sec. 414.94(b), and ordered on or after January 1, 2019:
(1) Which qualified CDSM was consulted by the ordering professional;
(2) whether the service ordered would adhere to specified applicable
AUC, would not adhere to specified applicable AUC, or whether the
specified applicable AUC consulted was not applicable to the service
ordered; and (3) the NPI of the ordering professional (if different
from the furnishing professional).
We believe that, unless a statutory exception applies, an AUC
consultation must take place for every order for an applicable imaging
service furnished in an applicable setting and paid under an applicable
payment system. We further believe that section 1834(q)(4)(B) of the
Act accounts for the possibility that AUC may not be available in a
particular qualified CDSM to address every applicable imaging service
that might be ordered; and thus, the furnishing professional can meet
the requirement to report information on the ordering professional's
AUC consultation by indicating that AUC is not applicable to the
service ordered. We remind readers that, as required under Sec.
414.94(g)(1)(iii), qualified CDSMs must make available, at a minimum,
AUC that reasonably address common and important clinical scenarios
within all priority clinical areas. As discussed in the CY 2017 PFS
final rule (81 FR 80170), the current list of priority clinical areas
represents about 40 percent of advanced diagnostic
[[Page 53191]]
imaging services paid for by Medicare in 2014. We also remind readers
that consistent with section 1834(q)(4)(A) of the Act, ordering
professionals must consult AUC for every advanced diagnostic imaging
service ordered. Although section 1834(q)(4)(B) of the statute does not
prohibit qualified CDSMs to return a response of ``not applicable'' if
a qualified CDSM does not contain specified applicable AUC for the
service ordered, we expect these situations to be limited in scope and
number, and to decrease over time. The ``not applicable'' responses
should decrease as qualified PLEs continue to build out their AUC
libraries and qualified CDSMs update their content and potentially
collaborate with more qualified PLEs so as to make available highly
comprehensive tools.
Section 1834(q)(4)(B) requires that payment may only be made if the
claim for the advanced diagnostic imaging service includes the specific
information discussed in this final rule. This information, to the
extent feasible, is required across claim types (including both the
furnishing professional and facility claims) and across all three
applicable payment systems (PFS, hospital outpatient prospective
payment system and ambulatory surgical center payment system). In other
words, we would expect this information to be included on the
practitioner claim that includes the professional component of the
imaging service and on the hospital outpatient claim for the technical
component of the imaging service. Claims for services for which payment
is not made under the three identified payment systems would not be
required to include consultation related information.
To implement this requirement we proposed to establish a series of
HCPCS level 3 codes. These G-codes would describe the specific CDSM
that was used by the ordering professional. Ultimately there would be
one G-code for every qualified CDSM with the code description including
the name of the CDSM. However, because the claims processing system can
only recognize new codes quarterly, we may not be able to update the G-
code descriptors simultaneously with the announcement of any new
qualified CDSMs which is expected to occur in June of each year. To
ensure that there is a code available to immediately describe newly
qualified CDSMs, we proposed to establish a generic G-code that would
be used to report that a qualified CDSM was consulted, but would not
identify a specific qualified CDSM; clinicians would only be permitted
to use this code if a more specific named code did not yet exist for
that clinician's CDSM. Furnishing professionals would report this code
temporarily until a specific G-code describing the newly qualified CDSM
by name becomes available. We also proposed to establish a G-code to
identify circumstances where there was no AUC consultation through a
qualified CDSM. The description of this code would indicate that a
qualified CDSM was not consulted by the ordering professional.
G-codes would be a line-item on both practitioner claims and
facility claims. We would expect that one AUC consultation G-code would
be reported for every advanced diagnostic imaging service on the claim.
If there are two codes billed for advanced imaging services on the
claim then we would expect two G-codes. Each G-code would be expected,
on the same claim line, to contain at least one new HCPCS modifier. We
proposed to develop a series of modifiers to provide necessary
information as to whether, when a CDSM is used to consult AUC: (1) The
imaging service would adhere to the applicable appropriate use
criteria; (2) the imaging service would not adhere to such criteria; or
(3) such criteria were not applicable to the imaging service ordered.
We proposed to create additional modifiers to describe situations where
an exception applies and a qualified CDSM was not used to consult AUC:
(1) The imaging service was ordered for a patient with an emergency
medical condition or (2) the ordering professional has a significant
hardship exception. Based on this proposal we specifically sought
comments on any additional HCPCS modifiers that might be needed to
separately identify allowable scenarios for which a qualified CDSM was
not consulted by the ordering professional.
The following is a summary of the public comments received on our
proposals for the information furnishing professionals must report on
the Medicare claim:
Comment: Some commenters agreed with the proposed approach of using
a combination of G-codes and HCPCS modifiers to capture AUC
consultation information on Medicare claims. Numerous commenters,
however, stated that the creation of new G-codes and modifiers will
excessively burden practitioners and their systems. Practitioners and
facilities will have to dedicate significant staff time and in some
cases additional full-time staff positions to translating this new
information into the appropriate codes and ensuring such information is
appended to Medicare claims. Others noted that CDSMs, EHRs and systems
that create electronic orders will require additional programming and
testing. There was also concern that CMS would not be able to keep up
with timely issuing of G-codes to keep up with newly qualified CDSMs.
Commenters provided various recommendations to CMS that would avoid
the combination of reporting through G-codes and modifiers. A commenter
suggested that only one G-code be developed to generically identify
that a CDSM consultation occurred without identifying the specific
mechanism. Another comment pointed out that when the modifiers for
consultation exceptions are reported (for example, emergency medical
conditions or hardship exceptions) that the modifier should be
reporting on the same line as the CPT code for the imaging service as
opposed to reporting a G-code.
Many commenters suggested CMS require the unique consultation
identifier be appended to the Medicare claim instead of using G-code
and modifier combinations. They suggested CMS, along with stakeholders,
standardize the identifier to have embedded meaning that is consistent
across CDSMs. They further supported the reporting of this identifier
on claims so CMS can match the claim with the richer, more robust
consultation data that is collected within the CDSM. It is with this
more complete information that they suggested that outlier ordering
professionals be identified rather than rely solely on information
reported on the claim. Commenters generally supported use of the unique
identifier as the least administratively burdensome approach to
collecting AUC consultation information on Medicare claims.
Other commenters suggested a registry to hold all AUC consultation
information across CDSMs and that the information be available to CMS
directly from the registry rather than having furnishing professionals
report information on the claim. They further suggested that a registry
would also include information about consultations that do not result
in imaging.
Response: We agree with many of the commenters in that a less
burdensome approach to reporting AUC consultation information on
Medicare claims should be considered. Reporting the unique consultation
identifier would still be a new burden on the ordering and furnishing
professionals; however, we are pleased to learn from commenters that it
is a less burdensome and preferred approach when compared to the
proposed G-code and modifier combinations. We also agree that
[[Page 53192]]
capturing this identifier on the claim provides the best opportunity to
access the robust data contained within qualified CDSMs.
In response to these comments we will not move forward with the G-
code and modifier combinations for reporting which CDSM is consulted,
adherence, non-adherence or situations where AUC are not applicable. We
will further explore and pursue use of the unique consultation
identifier for reporting on Medicare claims. However, in order to use
such an identifier we must work with stakeholders to develop a standard
taxonomy. We expect to conduct stakeholder outreach during 2018 so that
such standardization can be accomplished and will discuss such changes
in future rulemaking ahead of the 2020 consulting and reporting
effective date. We do not anticipate including these identifiers on
claims before then. We will conduct outreach to better explore options
of where to place such an identifier on practitioner and facility
claims for advanced imaging services. We will also explore mechanisms
for CMS and qualified CDSMs to share data.
Since we intend to move forward to implement the AUC consultation
and reporting requirement under section 1834(q)(4) using the unique AUC
consultation identifier, we will not pursue the use of G-codes to
identify the consulted CDSM. It is our expectation that the information
required for Medicare claims processing and, ultimately, identification
of outlier ordering professionals, will be embedded within a
standardized unique identifier. AUC adherence, non-adherence and not
applicable responses should also be embedded. Therefore, we will not
move forward with the creation of modifiers to identify each of those
AUC consultation result conditions. We do expect that limited use of
modifiers will be required in the future to identify certain exceptions
to AUC consultation requirements.
In another section of this preamble we discuss the voluntary
reporting period that we proposed to be available from July 2018
through December 2018, and we are extending in this final rule through
CY 2019. During the voluntary reporting period, ordering professionals
are not required to consult AUC and furnishing professionals are not
required to report consultation information on their Medicare claims.
Furnishing professionals and facilities reporting AUC consultation
information during the voluntary reporting period will have one HCPCS
modifier available to them to report on the line level with the CPT
code for the advanced diagnostic imaging service. This modifier
identifies only that AUC was consulted and not the result of the
consultation. We expect this type of limited reporting will be
temporary as we move forward to implement the AUC consultation and
reporting requirements using the unique AUC consultation identifier.
Comment: A commenter asked whether claims for physicians billing
Medicare Part B services for advanced imaging services will require AUC
consultation when the patient is an inpatient.
Response: When the patient is in an inpatient setting and advanced
diagnostic imaging services are paid under Medicare Part A, the
physician's Part B professional claim would not require reporting of an
AUC consultation. Under section 1834(q)(1)(D) of the Act, the AUC
consultation and reporting requirements apply only in an ``applicable
setting'' which includes a physicians' office, hospital outpatient
department, ambulatory surgical center, or other ``provider-led
outpatient setting,'' but does not include any inpatient setting. The
ordering practitioner, in this example, would not be required to
consult a qualified CDSM.
Comment: A few commenters asked if orders for advanced diagnostic
imaging services for patients in critical access hospitals (CAHs) are
subject to the AUC consultation and reporting requirement.
Response: Any advanced imaging service furnished within a CAH would
not be furnished in an applicable setting. Applicable settings
currently include physician offices, hospital outpatient departments
and ambulatory surgical centers. CAH patients who are furnished an
advanced diagnostic imaging service in an applicable setting but the
claim for that imaging service is not paid under one of the applicable
payment systems would not require consultation and reporting of the AUC
consultation. This may apply in situations when a CAH has elected
Method II billing.
In response to the public comments, we are not moving forward with
requiring reporting of AUC consultation information on Medicare claims
using a combination of G-codes and modifiers. Rather, we will evaluate
a simplified method of reporting during the voluntary reporting period
using a single modifier while we work with stakeholders to explore
using a standardized unique AUC consultation identifier.
The following is a summary of public comments received on
communication of AUC consultation information between the ordering and
furnishing professionals:
Comment: Commenters suggested options be made available to report
situations when the furnishing professional attempted to obtain AUC
consultation information from the ordering professional but the
information was ultimately not made available. These commenters sought
an option to report on the furnishing professional claim that the
information was not provided. Some commented that furnishing
professionals should not be required to report the ordering
professional's compliance with the AUC program. They stated that this
unfairly punishes the furnishing professional.
Response: We understand that there is a burden placed on furnishing
professionals since it is their claims that ultimately will not be paid
if AUC consultation information is not included on the claim form.
However, section 1834(q)(4)(B) of the Act specifically requires that
this information be reported on the furnishing professional's claim. We
will continue to seek opportunities to reduce the reporting burden,
including use of the unique AUC consultation identifier.
Comment: Commenters widely requested further timely and detailed
guidance, clarification, and education on claims processing
requirements for reporting, certification and documentation. Commenters
requested specific information and examples on requirements and new
codes, and on how to report information such as hardship exception
information on the claim.
Commenters also requested clarification around a number of specific
issues. One commenter requested CMS provide instructions on how to
handle orders written prior to the effective date for the AUC
consultation and reporting requirement when services are furnished
after the effective date. One commenter requested clarification around
claims processing issues if the imaging test ordered does not match the
test performed because the furnishing professional modifies the order.
Several commenters requested clarification regarding the obligations on
ordering and furnishing professionals along with the consequences
during the educational and operations testing period, and specifically
asked whether claims will be paid during this period. Commenters also
requested clarification on which professional is responsible for the
accuracy of reporting, how CMS will ensure this, and the consequences
on furnishing professionals if the required information is not obtained
after the
[[Page 53193]]
educational and operations testing period. Some commenters requested
clarification on orders for repeat tests (for example, for the same
test to be performed every three months) and whether the same decision
support number could be used on each order or if a unique number was
required for each. One commenter requested we clarify that, when CMS
qualifies a PLE and their AUC development method, we are also accepting
the way the resulting level of appropriateness is translated to one of
the three options identified in our regulations (whether the service
ordered would adhere to specified applicable AUC, whether the service
ordered would not adhere to specified applicable AUC, or whether the
specified applicable AUC consulted was not applicable to the service
ordered) for the purposes of claims reporting. This commenter noted
that this is important to assure consistent translation (or mapping)
regardless of who performs the mapping.
Response: These comments and requests for clarification are helpful
and important as we develop and build out our outreach and education
strategies. We hope to engage in continuous communications with
stakeholders to address these and other questions that arise. As
discussed earlier, the AUC consultation and reporting requirements
begin for services furnished on or after January 1, 2020; so orders
placed for services that are furnished prior to this date are not
subject to the AUC consultation and reporting requirement. We are
exploring claims-reporting options for situations when the imaging
service is ordered before January 1, 2020 but furnished after January
1, 2020 and AUC consultation information is not available for inclusion
on the claim. During the educational and operations testing period,
beginning January 1, 2020 and continuing through December 31, 2020,
claims will be paid regardless of whether AUC consultation information
is correctly included on the claim. We hope practitioners will use this
time to make good faith efforts to accurately report information on the
claim so we can learn, adjust, and improve these processes and ordering
and furnishing professionals can learn and grow accustomed to
consulting AUC and reporting consultation information. Furnishing
professionals should expect ordering professionals to communicate
accurate information about their AUC consultations, so that such
information is reflected on the Medicare claim beginning January 1,
2020. We will continue to consider implementation of the exceptions to
AUC consultation during the voluntary reporting period and in response
to stakeholder feedback. We continue to explore options for reporting
this information in the least burdensome and most efficient manner and
will release specific instructions prior to January 1, 2020.
Voluntary and Educational and Operations Testing Periods
There are aspects of the AUC program that are novel for ordering
and furnishing professionals. An AUC consultation by an ordering
professional and reporting by a furnishing professional has never
before been required under Medicare Part B with such a broad
application (all professionals ordering and furnishing advanced
diagnostic tests). Additional considerations are warranted for the
complex communication that is required to convey AUC consultation
information from the ordering professional to the furnishing
professional and facility that must include that information when
billing for the service. Billing systems for furnishing professionals
will also need to include the AUC consultation information onto
Medicare claims forms. These processes are new for many professionals,
and there are many areas for potential missteps and errors. For these
reasons an educational and operations testing period is needed. During
this period, ordering professionals would consult AUC and furnishing
professionals would report AUC consultation information on the claim,
but we would continue to pay claims whether or not they correctly
include such information. This educational and operations testing
period allows professionals to actively participate in the program
while avoiding claims denials during the learning curve. It also gives
us an opportunity to make any needed claims processing adjustments
before payments are impacted.
We believe it is preferable to begin implementation with an
educational and operations testing period of a year. We do not expect
to continue this educational and operations testing period beyond the
first year of the AUC program.
We sought public comments on all aspects of our proposal, and
specifically, whether the AUC program requirements should be delayed
beyond the proposed start date of January 1, 2019. Although our
proposal to start the AUC program with an educational and operations
testing period beginning on January 1, 2019 was based in part on
comments received in prior rulemaking cycles, it was important to
receive comments to help us understand the current readiness of
stakeholders. In addition, we proposed that the program begin with an
educational and operations testing period and were interested in
comments regarding how long, if longer than one year, such a period
should be available.
In our proposals, we expected a voluntary reporting period to be
available prior to the beginning of the educational and operations
testing period and anticipated such voluntary period will begin in July
2018. When the voluntary period becomes available we will make
announcements through our educational channels such as the CMS Web site
and listservs. It is important to note that the educational and
operations testing period is separate from the voluntary reporting
period. During the voluntary reporting period, AUC consultation and
reporting are not required. However, for applicable imaging services
ordered on and after January 1, 2019, we proposed that ordering
professionals would be required to consult specified applicable AUC and
furnishing professionals would be required to report AUC consultation
information on the Medicare claim. We proposed further that the initial
year of the AUC consultation and reporting requirement would be an
educational and operations testing period during which we would
continue to pay claims whether or not they correctly include the
required information.
The following is a summary of the public comments received on the
proposed start date of January 1, 2019, our proposal to begin with a
year long educational and operations testing period, and the inclusion
of a voluntary reporting period ahead of the required AUC consultation
and reporting start date; and our responses to the comments:
Comment: Of the commenters supporting a 2019 start date the
majority also supported an educational and operations and testing
period. Some of those commenters further supported extending the
educational and operations testing period to two years, indicating that
two years is necessary for us to learn from the testing and make
adjustments before fully implementing the AUC program. Other commenters
supported starting the program in 2020 with the first two years being
for education and testing. Of the commenters that agreed with including
an initial period of educational and operations testing, or delaying
the first year of the program to 2020 or beyond, many cited concerns of
infrastructure
[[Page 53194]]
readiness, high administrative burden, lack of standards across CDSM
and EHR vendors, need to educate the affected professionals, time for
those professionals to overcome technical and workflow challenges, and
additional time for CMS to provide needed guidance including
establishing vendor standards for communication between the ordering
and furnishing professionals. Specifically, some commenters identified
concern over the lack of interoperability across CDSMs and the lack of
available CDSMs that are embedded within EHRs as a reason for delaying
the program start date. Also, they recommended CMS work with ONC to
establish applicable standards for AUC, CDSMs and their EHR
integration.
Although commenters pressed the need for predictability in the
start of the program and asserted that numerous professionals are ready
to begin, or are very close to beginning, to use CDSMs, other
commenters focused on the increased burden associated with this
program. Those commenters identified the Quality Payment Program as a
new program that is currently requiring extra resources and has
recently increased burden on the same practitioners and facilities that
will be burdened by the AUC program.
Some commenters suggested that, instead of beginning to implement
the AUC program broadly, we should begin smaller with focused pilots,
or a staged or incremental rollout.
Response: We understand that the AUC program is a new requirement
that increases the administrative burden on practitioners and
facilities that order and furnish advanced diagnostic imaging services.
For example, practitioners that do not have access to a qualified CDSM
within their EHR may experience greater interruptions to their clinical
workflows due to issues of interoperability or availability than
practitioners that do not have to leave their EHR environment to
consult a qualified CDSM. Allowing additional time for CDSMs and EHRs
to work together to improve workflow for practitioners may ease some of
the burden. In addition, we agree that there is value in ONC having a
role establishing standards for CDSMs and their EHR integration.
We believe this program can be implemented in a manner that would
minimize burden, but this will require additional stakeholder outreach,
collaboration and time. For practitioners and facilities that are ready
to use qualified CDSMs or that are new to CDSMs and want to practice
and refine their workflow, we are providing a voluntary period starting
in July of 2018 that runs through CY 2019.
Taking into account the comments related to burden and readiness,
we agree with the commenters recommending that the program begin in
2020 with an educational and operations testing period. Providing a
start date for implementation of the AUC consultation and reporting
requirement will also give some predictability and assurance to
practitioners. Given our intention to use the educational and
operations testing period to make needed adjustments to the program as
well as identify any needs for further guidance and education, we will
evaluate whether a second educational and operations testing year is
necessary. We believe it is appropriate to retain this option in the
event that, to be responsive to stakeholder feedback and the lessons we
learn, it is expedient to take additional time to fully implement the
AUC consultations and reporting requirements. However, since we
currently have qualified PLEs and qualified CDSMs, we expect to be
prepared to quickly begin a voluntary participation period. Since the
educational and operations testing period will not start until 2020, we
are extending the voluntary participation period to 18 months from July
2018 through December 2019.
Comment: Of the commenters that referenced the proposal to begin
the program with a voluntary reporting period, the majority stated
their support. However, some commenters expressed confusion about the
voluntary period and the educational and operations testing period.
They requested clarification regarding what is required of ordering and
furnishing professionals during those two periods.
Response: During the voluntary reporting period, consulting
specified AUC through a qualified CDSM and reporting AUC consultation
information will be completely optional. AUC consultation information
will not be required on Medicare claims for advanced diagnostic imaging
services during the voluntary reporting period. We intend to develop a
single HCPCS modifier to be used on claims during this period so the
furnishing professional may use the modifier when AUC consultation
information is provided by the ordering professional. Currently, we
expect that the use of the HCPCS modifier will be the extent of
reporting we can accommodate during the voluntary period. However, we
anticipate that more specific reporting of AUC consultation information
will be required when the educational and operations testing period
begins on January 1, 2020. Since the first year of required AUC
consultation and reporting will be an educational and operations
testing period, we will not deny claims that fail to properly include
AUC consultation information. We expect to adopt and communicate
additional details and expectations for AUC consultation and reporting
during the educational and operations testing period through further
rulemaking and guidance before January 1, 2020.
Comment: Commenters inquired about the responsibilities of the
ordering professional and requested guidance on how AUC consultation
information is to be communicated to the furnishing professional and
what must be included in the communication. Some commenters recommended
we require this information to be communicated using a unique
consultation identifier and require that information to be included on
the order from the ordering professional to the furnishing
professional.
Response: It is the responsibility of the ordering professional to
consult specified applicable AUC through a qualified CDSM and
communicate information on that consultation to the furnishing
professional. We recognize that there are many ways to communicate
orders (paper, fax, telephone) for advanced diagnostic imaging services
between ordering and furnishing professionals and we expect that the
information related to the AUC consultation would be communicated as
part of the order. If we adopt a policy to require reporting of the
unique AUC consultation identifier on the furnishing professional's
claim, then we would expect the ordering professional to include that
identifier on the order for the advanced diagnostic imaging service. We
understand that commenters are looking to us to provide prescriptive
guidance about how AUC consultation information is communicated between
the ordering and furnishing professionals; however, a first step may be
to fulfill the need to standardize the taxonomy of the unique
consultation identifier before we determine the extent to which we will
establish guidance.
Comment: Some commenters suggested that CMS establish a proactive
mechanism to review issues that arise during the voluntary and
educational and operations testing periods and develop solutions. One
commenter cited the way CMS handled the ICD-9 to ICD-10 coding
transition as a suggestion for how to implement AUC coding and claims
processing. Commenters also suggested using the voluntary reporting
[[Page 53195]]
and the educational and operations testing periods for CMS to offer
feedback to practitioners, develop targeted education and release data
to the public.
Response: We agree with commenters that it would be mutually
beneficial to develop a learning and feedback loop, so we will explore
a plan to provide feedback and education to practitioners during the
voluntary and educational and operations testing periods. We will
explore this further through additional stakeholder outreach. It is
unlikely that we will have the same level of resources to devote to
this program that were available for the ICD-9 to ICD-10 transition,
but we will consider and work toward developing the ability to monitor
these claims and provide feedback in a more real-time manner.
In response to the public comments, and in addition to delaying the
effective date for requiring AUC consultation and reporting as
described earlier in this section, we are extending the voluntary
period through 2019, so it will begin in July 2018 and end at the end
of December 2019. The voluntary period will then be immediately
followed by the educational and operations testing period in 2020
during which claims will not be denied for failure to include proper
AUC consultation information.
b. Alignment With Other Medicare Quality Programs
The CY 2017 Merit-based Incentive Payment System and Alternative
Payment Model final rule with comment period (Quality Payment Program
final rule) (81 FR 77008) finalized policies to implement a new
approach to payment for physicians and other eligible clinicians,
enacted by the MACRA, that rewards the delivery of high-quality patient
care through two avenues: Advanced Alternative Payment Models (APMs)
and the Merit-Based Incentive Payment System (MIPS) under the PFS. We
expect the Quality Payment Program to evolve over multiple years and to
continue iterating on these policies. We also believe the AUC program
has the potential to provide new opportunities to improve care delivery
by supporting and rewarding clinicians as they find new ways to engage
patients, families and caregivers as well as improving care
coordination and patient health management.
Therefore, we proposed in the CY 2018 Updates to the Quality
Payment Program proposed rule (82 FR 30010) to develop a direct tie
between MIPS and the AUC program. In that rule, we proposed to give
MIPS credit in the improvement activities performance category to
ordering professionals for consulting specified AUC using a qualified
CDSM as a high-weight improvement activity for the performance period
beginning January 1, 2018 (82 FR 30484). We believe this will
incentivize early use of qualified CDSMs to consult AUC by motivated
eligible clinicians looking to improve patient care and to better
prepare themselves for the AUC program. Although we proposed that the
AUC program consultation and reporting requirements would not
officially begin until January 1, 2019, we are able to adopt this
proposed improvement activity because the first qualified CDSMs were
announced in conjunction with the CY 2018 PFS proposed rule; therefore,
ordering professionals will be able to begin consulting specified,
applicable AUC using those tools.
We also considered how the AUC program could serve to support a
quality measure under the MIPS quality performance category, and sought
feedback from the public regarding feasibility and value of pursuing
this idea further.
The following is a summary of the public comments received on how
the AUC program could serve to support a quality measure under the MIPS
quality performance category, and feedback regarding feasibility and
value of pursuing this idea further; and our responses:
Comment: Commenters were supportive of the proposed improvement
activity described in the CY 2018 Quality Payment Program proposed
rule. Most commenters directly stated that this proposed activity
should be finalized and maintained as a high weight activity for the
2018 MIPS performance period and also future years by making the
improvement activity and associated weight permanent. A few commenters
simply stated agreement with the proposal to make AUC consultation an
improvement activity, while other commenters noted that the proposal
only ties the MIPS improvement activity points to the ordering
physician, which seems like a step in the correct direction but, alone,
is unlikely to prompt a significant increase in use of AUC. Commenters
offered additional proposals to expand the scope of the proposed
improvement activity including suggestions that: (1) Eligible
clinicians could receive credit for AUC consultation through both the
MIPS quality and improvement activities performance categories; (2) we
should further incentivize the electronic ordering of advanced
diagnostic imaging services; (3) credit would be awarded if the rate of
consultation with AUC is 60 percent for first year, or 75 percent for
the second year similar to IA _PSPA _6 ``Consultation of the
Prescription Drug Monitoring program''; (4) we should award credit for
consultation with AUC through CDSMs that have not been qualified; (5)
we should provide credit to those eligible clinicians providing
radiological consultative services; (6) credit should be given for
reporting of the AUC consultation by furnishing professionals; and (7)
MIPS credit should be awarded to those clinicians directly involved in
AUC development. One commenter did not support providing a high-level
improvement activity credit under the MIPS for mandatory clinical
decision support use stating that such credit is intended for voluntary
improvement efforts by clinicians, and thus is not appropriate for
mandated activities. One commenter suggested that it is not appropriate
to incentivize CDS program adoption with MIPS before at least January
1, 2019.
Response: We agree with recommendations that we work closely to
align quality improvement mechanisms in the Medicare program. The
improvement activity proposal is addressed in rulemaking for the
Quality Payment Program. We note that we continue to believe this
proposal is useful to encourage early adoption of, and maximize the
movement to, voluntary AUC consultation and reporting as the AUC
program moves towards full implementation. We recognize that there are
further opportunities for alignment between the AUC program and the
Quality Payment Program, but did not propose additional policies in
rulemaking for CY 2018. Therefore, we will consider these suggestions
further as we continue to collaborate with other quality improvement
programs and engage in future rulemaking.
Comment: Many commenters noted that current AUC program policies
and proposals are not yet tied to the MIPS quality or cost categories
in the CY 2018 Quality Payment Program proposed rule. However,
commenters were divided on the extent to which the AUC program could
feasibly align with MIPS beyond the proposed improvement activity
performance category. A few commenters believed that use of a qualified
CDSM should be incorporated into MIPS only as an improvement activity.
One commenter noted that, at best, any proposed AUC program quality
measure would be a process measure, suggesting that measures of
outcomes are preferable. A few commenters discouraged creation of
quality measures around the consultation of AUC based on
[[Page 53196]]
administrative claims. Other commenters stated that creating a quality
measure would be moving closer to more directly tying AUC consultation
to payment for the ordering professional, potentially through MIPS
performance scoring, which runs contrary to the statutory requirement
that the furnishing professionals' claims and payment are directly
impacted.
A few commenters stated they look forward to working with us to
develop and implement appropriate measures that will further align the
AUC program with the Quality Payment Program. Several commenters
submitted additional proposals to better align the AUC program to
additional MIPS performance categories. One commenter believed that if
the certified EHR technology (CEHRT) requirements were expanded to
include the requirement for CDSM functionality within computerized
physician order entry modules, the alignment between the AUC program
and the MIPS ACI performance category would be further reinforced. A
few commenters noted the currently available appropriate use measures,
including measures for cardiac imaging, and suggested that such
measures could be leveraged as models for applying AUC to more areas of
advanced diagnostic imaging, which the commenters believed to be
responsive to the request to align the AUC program with the Quality
Payment Program. One commenter recommended that any potential quality
measure developed around AUC would have to meet the standards set for
other quality measures--reliability, validity, and testing. Specific
suggestions from commenters also included the framework for creation of
a new quality measure. For example, commenters suggested that a quality
measure could assess whether a clinician consults specified, applicable
AUC using a qualified CDSM or other tool. Another proposal included an
optional quality measure or bonus points in MIPS if physicians provide
feedback to PLEs and CDSMs about why they decided to proceed with
ordering an applicable imaging service when it does not adhere to the
specified applicable AUC consulted, thus enabling PLEs and CDSMs to
learn from user experience. Another commenter recommended that CDSMs
could support such feedback and improvement efforts by including
applications for practitioners to download to mobile devices, thus
allowing ordering professionals to consult AUC using an intuitive flow-
chart based interface. One commenter asked that any AUC-related measure
provide two points for reporting on appropriate use, suggesting that
such a proposal would further incentivize reporting on an appropriate
use measure. One commenter suggested that greater alignment with the
quality performance category of MIPS could be achieved through
utilization of a Qualified Clinical Data Registry (QCDR) that
incorporates CDSMs and reports information on the physician's behalf.
The commenter believed that a registry approach would be simpler,
provide essential data, and potentially avoid clinician burden as a
result. Finally, a few commenters strongly urged full alignment of the
AUC program with the MIPS cost or quality performance categories and
complete discontinuation of the AUC program and its regulatory burden.
Response: We thank all the commenters for their consideration and
feedback about additional MIPS performance categories that could be
better aligned with the AUC consulting and reporting requirements. We
appreciate the thoughtful comments on ways we could connect the AUC
program with the Quality Payment Program in order to reach a less
burdensome approach to the AUC program, and will also consider these
suggestions.
In response to public comments, we have finalized this improvement
activity in the CY 2018 Updates to the Quality Payment Program final
rule and note here that the description was updated such that
clinicians attest that they are consulting specified applicable AUC
through a qualified CDSM for all applicable imaging services furnished
in an applicable setting, paid for under an applicable payment system,
and ordered on or after January 1, 2018.
c. Significant Hardship Exceptions to Consulting and Reporting
Requirements
We proposed to modify Sec. 414.94(i)(3) of our regulations to
reflect the conclusion of application of the payment adjustments under
the Medicare EHR Incentive Program and to substitute an alignment with
the advancing care information (ACI) performance category of MIPS. In
the CY 2017 PFS final rule, for purposes of the AUC program significant
hardship exceptions, we included the following categories from Sec.
495.102(d)(4):
Insufficient Internet Connectivity (as specified in Sec.
495.102(d)(4)(i)).
Practicing for less than 2 years (as specified in Sec.
495.102(d)(4)(ii)).
Extreme and Uncontrollable Circumstances (as specified in
Sec. 495.102(d)(4)(iii)).
Lack of Control over the Availability of CEHRT (as
specified in Sec. 495.102(d)(4)(iv)(A)).
Lack of Face-to-Face Patient Interaction (as specified in
Sec. 495.102(d)(4)(iv)(B)).
In addition, in the CY 2017 Quality Payment Program final rule, we
finalized a policy (81 FR 77240-77243) to reweight the ACI performance
category to zero in the MIPS final score for the year for MIPS eligible
clinicians who meet the criteria in one of the listed categories of
Sec. 495.102(d)(4), with the exception of the category for clinicians
practicing for less than 2 years. Under section 1848(q)(1)(C)(v) of the
Act, eligible clinicians who first enroll in Medicare during the
performance period for a year and have not previously submitted claims
under Medicare are not considered MIPS eligible clinicians, and thus
are excluded from MIPS. Therefore, many clinicians who have been
practicing for less than 2 years would be excluded from MIPS on the
basis that they are new Medicare-enrolled MIPS eligible clinicians as
defined in Sec. 414.1305. Because these clinicians are not MIPS
eligible clinicians, they would never meet the criteria for re-
weighting of their MIPS ACI performance category for the year.
Therefore, to implement a hardship exception for purposes of the AUC
program that is both operationally consistent and administratively
efficient, we proposed to remove as a criterion for a significant
hardship exception for the AUC program the criterion specified in Sec.
495.102(d)(4)(ii) of our regulations for those practicing for less than
2 years. We proposed to keep the remaining listed categories including
insufficient internet connectivity, extreme and uncontrollable
circumstances, lack of control over availability of CEHRT and lack of
face to face patient interaction. We noted that section
1843(q)(4)(C)(iii) of the Act only allows the ordering professional to
seek a significant hardship exception, not the furnishing professional.
As such, we proposed to amend the AUC significant hardship
exception regulation to specify that ordering professionals who are
granted re-weighting of the ACI performance category to zero percent of
the final score for the year under MIPS per Sec. 414.1380(c)(2) due to
circumstances that include the criteria listed in Sec.
495.102(d)(4)(i), (iii), (iv)(A) and (iv)(B) would be excepted from the
AUC consultation requirement during the same year that the re-weighting
applies for purposes of the MIPS payment adjustment.
[[Page 53197]]
There will be scenarios when a clinician's experience of a
significant hardship or extraordinary circumstance does not align with
the prospective identification of these ordering professionals with
reference to MIPS criteria and processes. However, we believe the
prospective identification process allows us to apply exceptions in
real-time for claims submitted for advanced imaging services. There are
timing differences between the MIPS and the AUC program (the MIPS
payment adjustment year is based on performance in a prior year while
the Medicare AUC program requires real-time AUC consultation and
claims-based reporting). In addition to the timing, there will be
instances when a clinician who is not a MIPS eligible clinician will
need to seek a significant hardship exception to the Medicare AUC
program. To accommodate these two separate scenarios, we proposed to
establish a process to identify ordering professionals in need of a
significant hardship exception to the Medicare AUC program requirements
that is outside the MIPS re-weighting process. For purposes of these
scenarios, we proposed to use the criteria for clinicians seeking an
AUC significant hardship exception described under Sec. 495.102(d)(4)
to include (i), (iii), (iv)(A) and (iv)(B) of our regulations. We
proposed these criteria to align with the criteria used under MIPS for
re-weighting under the ACI performance category, and to provide
predictability and consistency to the determination of significant
hardship. We further proposed that a significant hardship exception
from the Medicare AUC program requirements would be granted for no
longer than 12 months, and that we could establish an exception for a
shorter period where warranted by the circumstances.
Therefore we proposed that ordering professionals who have not
received a re-weighting to zero for the MIPS ACI performance category
for the year, but experience one of the circumstances described in
Sec. 495.102(d)(4) to include (i), (iii), (iv)(A) and (iv)(B), may be
granted an AUC significant hardship exception for no longer than one
year.
In addition to these proposals, we invited the public to comment on
additional circumstances for which it may be appropriate for an
ordering professional to be granted a significant hardship exception
under the AUC program.
The following is a summary of the public comments received on our
proposed modifications to the AUC program significant hardship
regulation language, proposal to grant a significant hardship exception
for no longer than 12 months, and additional circumstances for which it
may be appropriate for an ordering professional to be granted a
significant hardship exception under the AUC program; and our
responses:
Comment: Many commenters thanked us for adopting policies to
provide for significant hardship exceptions for the AUC program in the
CY 2017 PFS final rule, and for working to align AUC program
significant hardship exceptions with those under the MIPS as proposed
in the CY 2018 PFS proposed rule. These commenters supported alignment
between the proposed changes to the AUC significant hardship exception
policy and the significant hardship exceptions proposed in the CY 2018
Updates to the Quality Payment Program proposed rule. Several
commenters requested that CMS finalize these hardships for the AUC
program as proposed. These commenters further believed that identifying
ordering professionals with significant hardship exceptions creates
challenging workflows for furnishing professionals. The furnishing
professionals must have this information so they are aware which of the
claims require AUC consultation information to be reported and which do
not. One commenter expressed specific concern about the increased
resources and burden of identifying, tracking, and reporting which
ordering professionals have significant hardship exceptions. One
commenter explicitly concurred with the proposed AUC program hardship
exceptions available for certain eligible clinicians as outlined in the
proposed rule, and with providing for exceptions for periods of no
longer than 12 months at a time.
In contrast, a few commenters did not understand why such hardship
exceptions were proposed within two different programs (the AUC program
and the MIPS). These same commenters opposed our proposal to exclude
from the hardship exception categories under the AUC program the
category for clinicians who have been practicing for fewer than 2
years. Other commenters expressed concern that under our proposals all
radiologists who meet the lack of face-to-face patient interaction
threshold would be excepted from consulting AUC if they order
applicable imaging services. In addition, many commenters believed that
certain hardships may justifiably last longer than 12 months and the
circumstances leading to the initial request for a significant hardship
may be uncontrollable by the physician. These commenters opposed the
12-month cap on hardship exemptions and further stated that such an
approach is unfair, unjustified, and disproportionately affects rural
providers.
A few commenters believed it was unreasonable to recognize eligible
clinicians who have their MIPS ACI performance category re-weighted to
zero for the reason that the ordering professional practices at
multiple locations, without also considering an exception for other
practitioners that face challenges to controlling their CEHRT such as
ASC-based eligible clinicians. Those commenters support these
categories as qualifying for a significant hardship exception under the
AUC program. A few commenters believed that we must also include an
exception for hospital-based physicians because emergency physicians
and practitioners could not purchase a CDSM platform or adopt a free
CDSM platform, for implementation in the hospital because they do not
have the appropriate authority to make such purchases or to implement a
new CDSM for the delivery of emergency medical care provided in the
hospital emergency department setting. To this end, commenters urged
inclusion of the statutory references to hospital-based physicians and
ASC-based MIPS eligible clinicians into existing exceptions from AUC
requirements for MIPS eligible clinicians who have their ACI
Performance Category reweighted to zero.
Response: We appreciate the views of commenters that agreed with
our proposals and those that questioned the extent of alignment we
proposed with the MIPS re-weighting policies for the ACI performance
category. In response to public comments that varied widely in content
and tone, we are not finalizing the proposed changes to the significant
hardship exceptions in this final rule. Commenters offered extensive
suggestions for modifications to our proposed updates to the
significant hardship exceptions under the AUC program. After
considering these comments, we have decided further evaluation is
needed before making changes to the significant hardship exception
regulatory language. We will reflect further on both the public
comments on our proposals, as well as the policies adopted in the CY
2018 Quality Payment Program final rule with comment period, before
proposing any revisions to the significant hardship exceptions for the
AUC program. In rulemaking for CY 2019, we intend to address policies
on significant hardship exceptions for the AUC program that take into
account points raised in public comments, as well as the requirements
[[Page 53198]]
of the statute and the goal to align as closely as possible with other
quality program exceptions and mechanisms for seeking and obtaining
exceptions so as to avoid unnecessary administrative burdens. As such,
we are not revising our regulation at section 414.94(i)(3) in this
final rule.
We provide responses to the comments below to inform commenters of
our current thoughts despite not finalizing the changes we proposed to
the significant hardship exception under the AUC program.
Comment: Many commenters encouraged expansion of the scope of
available significant hardship exceptions. Commenters suggested the
following additional circumstances for which an ordering professional
should be granted a significant hardship exception under the AUC
program: (1) Imaging services ordered as part of clinical research; (2)
emergency clinicians attempting to meet the current exclusion criteria;
(3) physicians nearing retirement or dealing with hardships who may not
have data systems, capital, or the desire to invest in a qualified CDSM
system necessary to consult AUC; (4) any time when a PLE or CDSM is de-
qualified; (5) for complex medical systems; (6) any physician who does
not have access to free integrated CDSMs; and (7) physicians whose EHR
cannot integrate into an existing qualified registry.
To support some of these requests for additional exceptions,
commenters noted that a CDSM is a form of health information technology
that is routinely incorporated into EHR systems, and that costs are
associated with such integration. Commenters also stated that a free
tool is an impractical solution for those practices focused on
investing in upgrading to certified 2015 Edition EHR technology or
unable to afford acquisition of a CDSM that integrates with an EHR
system. More than one commenter cited the GAO's 2015 evaluation of the
Medicare Imaging Demonstration which reported frustration on the part
of ordering professionals when decision support was not integrated with
their EHRs. This demonstration was authorized by Congress to test
whether clinicians would change their ordering patterns (for example,
reducing inappropriate imaging) as a result of using appropriateness
guidelines for advanced imaging services through decision support
systems.
Response: We appreciate the additional context the commenters
provided about the rationale to support additional categories of
significant hardship exceptions under the AUC program. We will take
these comments into account for future rulemaking. We are not
finalizing our proposed significant hardship exceptions policies in
this final rule, and instead intend to address significant hardship
exceptions for the AUC program through rulemaking for CY 2019.
Comment: Commenters took interest in the proposed identification of
a re-weighting policy under the ACI performance category of MIPS for
MIPS eligible clinicians in small practices. Some commenters noted that
small, rural, and independent practices are not ready for AUC program
implementation, adding that AUC features within EHRs will be costly,
and using these features will take additional time away from patient
care. One commenter stated that modifications to either the EHR
environment or the CDSM capabilities may be challenging, even for large
organizations with greater resources, but especially for small entities
or practices. Although a few commenters recognized that while the
statute did not authorize a significant hardship exception category for
ordering professionals that order a low-volume of advanced imaging
services, these same commenters also believed that the statute did give
the Secretary discretion on a case-by-case basis to establish hardship
exemptions under which low-volume ordering professionals could qualify
for significant hardship.
Some commenters requested consideration for exempting ordering
professionals based on a low-volume threshold of services. One
commenter requested that if the proposed threshold for what constitutes
low volume under the CY 2018 Updates to the Quality Payment Program is
finalized, that these eligible clinicians also be excluded from the AUC
program. Another commenter submitted an alternative proposal that
instead of using the same low volume threshold proposed for MIPS a
threshold that more closely reflects advanced diagnostic imaging
services and billing would be an acceptable threshold calculation for
such an exception. Another commenter recommended adaptation of an
exception similar to those used in the Medicare e-prescribing (eRx)
program, which allowed individual eligible professionals who had been
successful electronic prescribers in 2011, and had reported the G8553
code via claims for less than 10 billable Medicare Part B PFS services
provided January 1, 2012 through June 30, 2012 to avoid the 2013 eRx
payment adjustment. In addition, one commenter requested a significant
hardship exception category for furnishing professionals that furnish a
low-volume of advanced imaging services, and supported this request
with the statement that it would be unreasonable to forgo any payment
for advanced diagnostic imaging services furnished under this program.
Response: We appreciate the suggestions for additional
opportunities to align the AUC program with the Quality Payment
Program. Section 1834(q)(4)(C)(iii) of the Act authorizes the
Secretary, on a case-by-case basis, to determine, subject to annual
renewal, that consultation with applicable AUC for an applicable
imaging service ordered by and ordering professional would result in a
significant hardship, such as in the case of a professional who
practices in a rural area without sufficient Internet access. In the CY
2018 Quality Payment Program proposed rule (82 FR 30076), we proposed
to re-weight the ACI performance category in MIPS to zero to recognize
that eligible clinicians who would have struggled to satisfy the
requirements of meaningful use would also struggle to report within the
ACI performance category on their CEHRT, for instance if they cannot
afford or have not adopted EHRs. In contrast, the AUC program did not
include such considerations, and further made available mechanisms
independent from CEHRT and free of charge. Therefore we will continue
to examine the significant hardship exceptions allowed under the
statute in order to identify appropriate areas of future alignment with
the Quality Payment Program as applicable to the AUC program.
Comment: Commenters sought clarification on the processes and
procedures for the hardship application and approval. Some commenters
requested a process by which MIPS eligible clinicians could apply for
an AUC program hardship exemption following the ACI hardship exemption
application deadline. One commenter requested implementation of a year-
round application process that will cover both the AUC program for the
ordering professional, and the ACI performance category of MIPS for
eligible clinicians.
Response: We thank these commenters for their suggestions and
considerations for a hardship application and approval process. We
agree that it is important for a process to be available throughout the
year. It is important to note that, since publication of our proposals
in the CY 2018 PFS proposed rule, the 2017 Quality Payment Program
hardship exception application was posted at: https://cmsqualitysupport.service-now.com/exception_application.do. We look
[[Page 53199]]
forward to working to align our AUC program significant hardship
exception process with existing processes through future rulemaking.
Comment: A few commenters observed that all significant hardship
exceptions include the additional burden furnishing professionals face
to verify that ordering physicians have in place a significant hardship
exception at the time a service is ordered. Therefore, commenters
requested a unique identifier for ordering professionals that have
obtained a hardship exception and requested such information be
prospectively publicly available. Commenters noted that this proposal
would allow significant hardship exceptions to apply in real-time for
claims submitted for advanced diagnostic imaging services, and
requested that the furnishing professional's claim should not be denied
payment if the ordering professional did not in fact have in place a
significant hardship exception from the AUC consultation requirement.
Another commenter requested that information on ordering professionals'
significant hardship status should be published no less frequently than
every two weeks. One commenter sought clarification about the situation
where an ordering professional is in the process of applying for a
hardship but has not yet received a significant hardship exception.
Another commenter sought clarity as to whether the hardship exception
applies to the clinician's NPI or the clinician's NPI and TIN.
Response: We agree that the communication about a significant
hardship exception from an ordering professional to a furnishing
professional introduces potential challenges. We will continue to
explore opportunities to use a more automated process for providing
additional information to ordering and furnishing professionals in a
timely manner in order to facilitate such communication and make the
information readily accessible.
As stated earlier we will not move forward with the proposed
significant hardship exceptions and will maintain our regulations at
Sec. 414.94(i)(3). This current policy provides exceptions from
consulting and reporting requirements for orders for applicable imaging
services made by ordering professionals who are granted a significant
hardship exception to the Medicare EHR Incentive Program payment
adjustment for that year. The basis for granting a significant hardship
exception to the ordering professional are identified under Sec.
495.102(d)(4) of this chapter, and include the following as discussed
in CY2017 PFS final rule: Lacking sufficient Internet access;
practicing for less than 2 years, facing extreme and uncontrollable
circumstances; practicing at multiple locations and demonstrating
inability to control the availability of CEHRT; and, lacking face-to-
face or telemedicine interaction with patients and a lack of need for
follow up with patients. We believe that during the voluntary reporting
period, we will continue to develop our understanding of the workflows
of both ordering and furnishing professionals, and in particular how we
can apply section 1834(q)(4)(C)(iii) of the Act to support those
ordering professionals whose consultation would result in a significant
hardship.
5. Summary
Section 1834(q) of the Act includes rapid timelines for
establishing a Medicare AUC program for advanced diagnostic imaging
services. The impact of this program is extensive as it will apply to
every physician or other practitioner who orders or furnishes advanced
diagnostic imaging services (for example, magnetic resonance imaging
(MRI), computed tomography (CT) or positron emission tomography (PET)).
This crosses almost every medical specialty and could have a particular
impact on primary care physicians since their scope of practice can be
quite broad. Stakeholders have expressed concern that program
requirements may inadvertently encourage physicians to order imaging
services that they do not believe are right for their patients. The
goal of evidence-based AUC is to assist clinicians in ordering the most
appropriate imaging service for their patients' specific clinical
scenarios. However, to ensure we are implementing the program
effectively, we requested public comment on such potential unintended
consequences. Additionally, as we continue to develop the AUC program,
we continue to engage a variety of stakeholders interested in
participating in the development of AUC. We sought comment about how we
can continue to engage interested participants, consistent with
statutory requirements at section 1834(q) of the Act, in developing AUC
in a transparent and scientifically robust manner. We are particularly
interested in how qualified PLEs develop or modify AUC in collaboration
with non-PLE entities and what additional challenges such entities
might face.
The following is a summary of the public comments received on
issues we solicited including potential unintended consequences of the
AUC program requirements as well as how we can continue to engage
interested participants, particularly qualified PLEs in collaboration
with non-PLEs, consistent with statutory requirements at section
1834(q) of the Act, in developing AUC in a transparent and
scientifically robust manner and our responses:
Comment: Many commenters shared their thoughts on potential
unintended consequences that may result from implementation of the AUC
program. Some commenters noted issues of patient access and delivery of
care. Commenters warned of the risk of decreased patient access or
choices, inappropriate underutilization of imaging studies and harm to
patients because of such a reduction, inappropriate testing to avoid
AUC requirements, delays in beneficiaries receiving needed tests or
even denial of services by furnishing professionals and facilities if
AUC is not consulted or information is not provided by the ordering
professional, and healthcare rationing. Commenters also warned that the
AUC program requirements could result in a shift in referral patterns
among primary care physicians and cardiologists and cautioned that the
program requirements could lead to disruptions in physicians' practices
and workflows and a reduction in patient facing time for providers.
Commenters also noted the potential for unwarranted financial penalties
for imaging facilities and increases in the cost of tests as CDSMs may
recommend higher cost imaging. Commenters noted a risk of impeding
clinical research involving imaging, particularly research on new
imaging decision rules, which would dramatically slow the generation of
relevant published evidence and limit the ability of qualified PLEs to
expand the scope of coverage and improve the quality of evidence-based
AUC. One commenter stated that there is no evidence that an unintended
consequence of AUC consultation is the ordering of imaging services
that ordering professionals do not believe are right for their
patients.
Response: We appreciate the time and energy commenters and
stakeholders have dedicated to share ideas, suggestions, feedback and
critiques of our progress in implementing the AUC program. Throughout
this preamble, we discuss ways to avoid these unintended consequences
as identified by commenters. We appreciate being alerted to these
potential unintended consequences so that we can closely monitor and
mitigate these issues should they arise during the voluntary
[[Page 53200]]
and educational and operations testing as we proceed to implement this
program.
Comment: Some commenters expressed concerns regarding the
definition of PLE codified in Sec. 414.94(b) of our regulations in the
CY 2016 PFS final rule with comment period and the avenues by which
entities not meeting the definition PLE can participate in the AUC
program. These commenters reiterated their previously expressed
opposition to the regulatory definition of PLE and requested revisions
to allow participation by more organizations, inclusive of independent
content developers, which they deem to be more reflective and in the
spirit of the language in the statute describing a PLE.
One commenter noted that organizations where practitioners are
involved in day-to-day management or providing strategic direction and
can deploy a rigorous evidence-based process for developing AUC should
be included. Another commenter stated that CMS prioritizes content
developed by clinicians who see patients over those who specialize in
reviewing science and developing guidelines so the definition does not
account for the fact that clinicians who spend most of their time
seeing patients do not have the capacity to develop and regularly
update comprehensive care guidelines. One commenter recommended
revising the definition to include organizations that develop AUC under
the leadership of a structured group of providers who are actively
engaged in the practice and delivery of healthcare as the regulatory
definition is inappropriately restrictive and limits the organizations
that may contribute to provider-developed AUC.
Response: We appreciate these comments and recommendations. We
understand the disagreement with the regulatory definition established
in the CY 2016 PFS final rule with comment period, but continue to
believe it is an accurate and appropriate interpretation of the
provisions added by the statute. We believe there are feasible options
for AUC content developers to participate in the AUC program regardless
of organizational structure, and thus, do not believe a modification to
the regulatory definition of PLE is warranted. Moreover, we did not
propose to modify the definition of PLE in the CY 2018 PFS proposed
rule. Therefore, we are making no changes to the definition of PLE this
year.
Comment: These commenters also questioned the endorsement pathway
codified in Sec. 414.94(d) of our regulations in the CY 2016 PFS final
rule with comment period whereby qualified PLEs may endorse the AUC of
other qualified PLEs, under agreement by the respective parties, to
enhance an AUC set. Commenters stated that this pathway is inconsistent
with statutory language and Congressional intent because the law was
meant to allow content developers other than national medical
professional specialty societies and PLEs to participate in the AUC
program when a national medical professional specialty society or PLE
endorsed the organization's AUC content. Under the current regulatory
definition, commenters stated that independent content developers and
third party entities cannot participate in the AUC program. One
commenter stated that the endorsement pathway should enable
practitioners to use third party criteria to comply with the AUC
program requirements. These commenters requested that the regulations
be revised to reflect the intent and language in the statute, and to
allow PLEs to endorse AUC from any author or developer. Another
commenter recommended that CMS reiterate that each qualified PLE that
endorses another qualified PLE's AUC must document that it obtained the
organization's agreement, as some organizations are endorsing AUC
without an agreement.
Response: We understand the commenters' views in relation to the
AUC program statutory provisions and the endorsement pathway, and agree
that AUC developed by independent content developers, third parties or
non-PLE authors can play a valuable role under the AUC program.
However, we do not believe that AUC endorsed by any organization that
could meet the definition of PLE should be considered specified AUC
under this program. Rather, we have established specific requirements
for PLEs to be qualified in order to ensure that any AUC developed,
modified or endorsed by these organizations are scientifically valid,
transparent and are created using an evidence based methodology. To
ensure this requirement of section 1834(q)(2)(B) of the Act is
fulfilled, we must understand the processes PLEs use to develop or
modify AUC and are consistent with statutory requirements.
Comment: One commenter specifically stated that collaboration, as
discussed in the preamble of the CY 2016 PFS final rule with comment
period, between an organization that meets the regulatory definition of
PLE and third-party content developers that do not is unworkable
because it places unreasonable burdens on the PLEs who are responsible
for the associated legal, regulatory and compliance burden. In their
experience, this commenter noted that these issues have prevented
collaborations from moving forward.
Another commenter recommended that the efforts of PLEs be monitored
over the next four years before CMS takes action to establish new
directives regarding specific AUC and its development. This commenter
stated that PLEs are expected to establish new methods for
collaboration over this period of time.
Another commenter noted that there is benefit to collaboration
between qualified PLEs and non-qualified PLEs as well as between
qualified PLEs. This commenter also stated that collaborations with
non-qualified PLEs have highlighted the anxiety of these organizations
in being forced to adopt practices that may conflict with established
local best practices and reinforce that we should focus on eliminating
unnecessary imaging and construct AUC that acknowledge local
differences in care settings, expertise and best practices. One
commenter states that non-PLEs can bring significant, relevant
experience to the AUC development process and support for physicians
engaged in medical practice; and that relationships between PLEs and
non-PLEs can create significant value leading to improved care provided
they are clearly defined and transparent.
One commenter recommended that PLEs should be allowed to delegate
the AUC development process to third parties that demonstrate adherence
to the AUC program requirements for deploying a multidisciplinary team
with the requisite expertise, transparency and managing conflicts of
interest.
Response: As stated earlier, we strongly agree that non-PLE
organizations can play a valuable role under the AUC program. We have
already seen this demonstrated by collaboration arrangements between
qualified PLEs and third party organizations such as independent
content developers, and expect these collaborations to continue to grow
and evolve. We encourage stakeholders to explore options for
collaboration under the guidelines of this policy.
Comment: Some commenters expressed their opposition to the
transparency requirements for qualified PLEs codified in Sec.
414.94(c)(1) of our regulations in the CY 2016 PFS final rule with
comment period. Commenters stated that the transparency requirements
are inappropriate because they require developers to place their
intellectual property in the public domain and that the statute does
not include such transparency requirements. One commenter warned
[[Page 53201]]
that if guidelines are made available to the public for free, authors
will have less incentive to invest resources to keep guidelines updated
and participation of independent, evidence-based guideline authors with
no financial stake in the actual delivery of care will be limited.
Commenters recommended instead that we allow alternative methods for
making AUC information available upon request. For example, commenters
suggested that requirements can be met by granting access to providers,
beneficiaries and CMS to AUC on an as-needed basis or to customers
through password protected portals.
Response: We thank commenters for communicating concerns regarding
transparency and protecting intellectual property. We recognize the
importance and value of AUC that are developed by all authors and, as
discussed in previous responses, believe there are opportunities for
the participation by all content developers. Among other requirements,
the statute requires that we consider whether criteria (1) have
stakeholder consensus; (2) are scientifically valid and evidence based;
and (3) are based on studies that are published and reviewable by
stakeholders. We believe that to assure the public that all the
statutory considerations are taken into account, transparency of the
process is essential. This includes making publicly available the
people, methodologies, and evidence used by developers. Failing to be
transparent calls into question the degree to which AUC are indeed
evidence based. AUC developed using non-evidence based sources could
result in physicians and patients making the wrong decisions to guide
care. Transparency allows AUC to be vetted by all stakeholders,
including the patient and his/her physician, therefore allowing them to
make informed decisions.
Because transparency is a critical element of this program, we
established specific requirements for qualified PLEs to make
information publicly available through their Web sites. We believe
qualified PLEs may fulfill transparency requirements and still keep
track of who is accessing the information on their Web sites, for
example, some qualified PLEs require users to enter basic information
and register through the Web site to gain access to AUC information.
Comment: Most commenters recommended that we undertake increased
education efforts on the AUC program as a whole, as well as on more
specific elements, to enable professionals who order and furnish
advanced diagnostic imaging services to learn about and comply with the
program. Commenters suggested using a ``town hall'' approach to provide
further education and engage in listening sessions during the
educational and operations testing period to understand concerns and
challenges ordering and furnishing professionals experience. Commenters
recommended that during the voluntary period, codes and modifiers
should be adjusted based on solicited feedback from providers and
feedback on billing practices should be provided including the
identification of what must be fixed and confirmation when it is fixed.
Some commenters recommended direct communications with ordering
professionals to encourage program compliance as well as focused
education and outreach targeting ordering professionals who may not be
complying with program requirements during the educational and
operations testing period. Citing the lack of awareness of the AUC
program and requirements, one commenter suggested CMS leverage existing
communication channels to promote awareness as soon as possible and
allow professionals sufficient time to adopt workflows that can reduce
administrative burden.
Response: We thank commenters for the suggestions and
recommendations regarding outreach and education considerations and
strategies. This information will assist and inform our planning as we
move forward with the AUC program and focus more heavily on outreach
and education efforts. In particular, we look forward to exploring
opportunities for town halls, listening sessions and ways to leverage
communication channels and strategies already used successfully by
other CMS programs.
We continue to believe the best implementation approach is one that
is diligent, maximizes the opportunity for public comment and
stakeholder engagement, and allows for adequate advance notice to
physicians and practitioners, beneficiaries, AUC developers, and CDSM
developers. It is for these reasons we proposed to continue a stepwise
approach, adopted through notice and comment rulemaking. In summary, we
proposed policies to implement the third component of the AUC program--
the consulting and reporting requirements and the effective date on
which these requirements would begin. We proposed that ordering
professionals must begin consulting specified applicable AUC through
qualified CDSMs for applicable imaging services ordered on and after
January 1, 2019, and furnishing professionals must begin reporting AUC
consultation information on Medicare claims for advanced diagnostic
imaging services for which payment is made under an applicable payment
system as defined in Sec. 414.94(b) and ordered on or after January 1,
2019. We also proposed modifications to the significant hardship
exception to better align these exceptions under the AUC program with
those under existing quality programs. We invited the public to submit
comments on these proposals.
We believe the changes we are adopting to the policies we proposed
in the CY 2018 PFS proposed rule in response to public comments are
important to provide more time for ordering and furnishing
professionals, qualified PLEs, qualified CDSMs, CMS and other
stakeholders to prepare for and support successful participation in the
Medicare AUC program. These changes include the following: (1)
Extending the voluntary reporting period to 18 months starting July
2018 and continuing through CY 2019; and (2) making the AUC
consultation and reporting requirements effective for an educational
and operations testing period beginning on January 1, 2020, instead of
January 1, 2019 as proposed, to last through CY 2020. We are not
finalizing the changes to the significant hardship exceptions in this
final rule as we have decided further evaluation is necessary before
making changes to our regulations at section 414.94(i)(3). We intend to
take into consideration the public comments on our proposals, as well
as policies adopted in CY 2018 rulemaking for the Quality Payment
Program, and to address significant hardship exceptions for the AUC
program in rulemaking for CY 2019. We will reevaluate the proposals
regarding what information must be reported on the Medicare claim and
will further explore opportunities for stakeholder engagement.
We will continue to post information on our Web site for this
program accessible at www.cms.gov/Medicare/Quality-Initiatives/Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program.
F. Physician Quality Reporting System (PQRS) Criteria for Satisfactory
Reporting for Individual EPs and Group Practices for the 2018 PQRS
Payment Adjustment
1. Background
Section 1848(a)(8) of the Act provides that for covered
professional services furnished by an EP during each of 2015 through
2018, if the EP does not satisfactorily report data on quality
[[Page 53202]]
measures for covered professional services for the reporting period for
the year, the PFS amount for services furnished by such professional
during the year (including the PFS amount for purposes of determining a
payment based on such amount) shall be equal to the applicable percent
of the PFS amount that would otherwise apply to such services. For 2016
through 2018, the applicable percent is 98.0 percent. Thus, individual
EPs and group practices who did not satisfactorily report data on
quality measures for the CY 2016 reporting period are subject to a
downward payment adjustment of 2.0 percent to the PFS payment amount
for covered professional services they furnish in 2018.
2. Previously Finalized Satisfactory Reporting Criteria for Individual
EPs and Group Practices for the 2018 PQRS Payment Adjustment
We previously finalized the satisfactory reporting criteria for
individual EPs and group practices for the CY 2016 reporting period to
avoid the 2018 PQRS payment adjustment in the CY 2016 PFS final rule
(80 FR 71140 through 71250) at Sec. 414.90(j)(8) and (9) and Sec.
414.90(k)(5).
Table 18 in the proposed rule summarized the previously finalized
satisfactory reporting criteria for individual EPs (see 82 FR 34097) at
Sec. 414.90(j)(8) and Sec. 414.90(k)(5).
Table 19 in the proposed rule summarized the previously finalized
satisfactory reporting criteria for group practices via the group
practice reporting option (GPRO) (see 82 FR 34098 through 34099) at
Sec. 414.90(j)(9) and Sec. 414.90(k)(5).
3. Modifications to the Satisfactory Reporting Criteria for Individual
EPs and Group Practices for the 2018 PQRS Payment Adjustment
Since we finalized these requirements, we have heard from
stakeholders that EPs have had difficulty with the previously finalized
satisfactory reporting criteria for the CY 2016 reporting period, which
was the final reporting period for the PQRS. Specifically, we have
heard from stakeholders through written communications to CMS that EPs
have found the requirements complex, and had difficulty in
understanding the requirements to be a satisfactory reporter for PQRS.
Stakeholders have also requested that the requirements for the CY 2016
reporting period be aligned with those of the Quality Payment Program,
specifically the Merit-based Incentive Payment System (MIPS). In
particular, we have heard requests to lower the previously finalized
requirement from 9 measures across 3 NQS domains, where applicable, to
only 6 measures with no domain requirement associated with these
measures. While the PQRS and the MIPS are separate programs, we
understand that stakeholders would like to see greater continuity
between the final year of the PQRS and the beginning of the MIPS.
The final reporting period for the PQRS was CY 2016. The Quality
Payment Program, authorized by the Medicare Access and CHIP
Reauthorization Act of 2015 (MACRA), consolidates and replaces three
existing programs (the Medicare EHR Incentive Program for EPs, the
PQRS, and the Value-Based Payment Modifier (VM)). There are two ways
eligible clinicians can participate in this program: (1) Through the
MIPS; and (2) through Advanced Alternative Payment Models (APMs). The
initial performance period for the MIPS began on January 1, 2017. Under
MIPS, there are four connected pillars that affect how MIPS eligible
clinicians will be paid by Medicare: Quality; Improvement Activities;
Advancing Care Information; and Cost. For more information on the
Quality Payment Program, see https://qpp.cms.gov/.
Although we understand that the data submission period for the CY
2016 reporting period has already ended and that all data that has been
submitted to CMS is based on the previously finalized satisfactory
reporting criteria for the CY 2016 reporting period, we revisited our
previously finalized policy because we wanted individual EPs and groups
to be assessed for purposes of the 2018 PQRS payment adjustment based
on satisfactory reporting criteria that are simpler, more
understandable, and more consistent with the beginning of MIPS. We
believe that such criteria will help clinicians more accurately gauge
their readiness for the beginning of MIPS and transition into the
Quality Payment Program successfully. Additionally, we want to be
responsive to the concerns of the clinician community. Therefore,
although we did not propose to collect any additional data for the CY
2016 reporting period, we proposed to modify the criteria we would
apply to the data already submitted for the CY 2016 reporting period to
determine whether an individual EP or group practice has satisfactorily
reported for purposes of avoiding the 2018 PQRS payment adjustment (82
FR 34099).
a. Individual EPs
Specifically, we proposed to revise the previously finalized
satisfactory reporting criteria for the CY 2016 reporting period to
lower the requirement from 9 measures across 3 NQS domains, where
applicable, to only 6 measures with no domain or cross-cutting measure
requirement (82 FR 34099). For individual EPs, this would apply to the
following reporting mechanisms: Claims, qualified registry (except for
measures groups), QCDR, direct EHR product and EHR data submissions
vendor product. This would not affect the criteria used to determine
whether an individual EP or group practice has satisfactorily reported
for purposes of avoiding the 2017 PQRS payment adjustment, with the
exception of the criteria applicable to individual EPs and group
practices reporting using the secondary reporting period established
under Sec. 414.90(j)(1)(ii) for the 2017 PQRS payment adjustment
(hereinafter referred to as the ``ACO Secondary Reporting Period''), as
discussed in section III.F.4. of this final rule.
Table 20 in the proposed rule summarized our proposed modifications
to the previously finalized satisfactory reporting criteria for
individual EPs to avoid the 2018 PQRS payment adjustment, based on data
previously submitted for the CY 2016 reporting period (82 FR 34100). We
did not propose to collect any additional data for the CY 2016
reporting period, as the data submission period for the CY 2016
reporting period had already ended. As summarized in Table 20 of the
proposed rule, the NQS domain requirement would no longer apply (82 FR
34100). No changes were proposed for the measures groups criteria.
Additionally, we also proposed that individual EPs and group
practices reporting via claims or qualified registry, as applicable,
would no longer be required to report a cross-cutting measure and that
individual EPs and group practices reporting via QCDR would no longer
be required to report an outcome or ``high priority'' measure (that is,
for purposes of PQRS, a resource use, patient experience of care,
efficiency/appropriate use, or patient safety measure) (82 FR 34100).
We note that what is considered to be a ``high-priority'' measure in
PQRS is different from what is considered a ``high-priority'' measure
in MIPS, and we did not propose to align this requirement with MIPS for
the last year of PQRS as this could cause confusion. Although certain
MIPS eligible clinicians are required to report at least one outcome or
other high-priority measure (see Sec. 414.1335(a)(1)(i)), we are also
not aligning the PQRS requirements with that MIPS requirement because,
although we agree that outcome and
[[Page 53203]]
high-priority measures are valuable for reporting, we want to revise
the satisfactory reporting criteria for the last year of PQRS to be
less complex for individual EPs and groups to understand.
Lastly, where we proposed to lower the requirement to only 6
measures, if less than 6 measures apply to the individual EP or group
practice, each measure that is applicable would need to have been
reported. We define ``applicable'' to mean measures relevant to a
particular individual EP's or group practice's services or care
rendered. As previously finalized, individual EPs and group practices
would continue to be subject to the measure application validity (MAV)
process (80 FR 71140 through 71145). The MAV process seeks to identify
clinically similar measures and creates clusters of measures that can
be reported if one of the measures in the cluster is reported. We will
maintain the requirement that each required measure be reported for at
least 50 percent of the individual EP's or group practice's patients to
which the measure applies.
Accordingly, we proposed to revise Sec. 414.90(j)(8) and (k)(5)
(82 FR 34101). We believe these proposals will result in fewer
individual EPs being subject to the 2018 PQRS payment adjustment, and
will impose no additional burden on individual EPs because this data
has already been submitted to CMS. We requested comment on these
proposals.
The following is a summary of the public comments received on these
proposals and our responses:
Comment: The majority of commenters supported our proposal to
revise the previously finalized satisfactory reporting criteria for the
CY 2016 reporting period to lower the requirement from 9 measures
across 3 NQS domains, where applicable, to only 6 measures with no
domain or cross-cutting measure requirement, primarily for its
alignment with MIPS reporting criteria.
Response: We appreciate the commenters' feedback, and agree that
the proposed changes to the reporting criteria are simpler, more
understandable, and more consistent with the MIPS quality reporting
requirements, and we are finalizing these changes as proposed.
Comment: Some commenters supported the proposed changes but urged
further reduction to reporting criteria, such as considering any
attempt of reporting to be satisfactory for purposes of avoiding a
downward payment adjustment.
Response: While recommendations to further reduce reporting
criteria were considered, we are finalizing the changes as proposed to
maintain alignment with MIPS quality reporting requirements. We believe
that requiring at least 6 measures provides a more accurate reflection
of the quality of care provided by an individual EP or group practice.
Comment: A few commenters opposed the proposed changes, as time and
resources have already been placed into reporting on the previously
finalized satisfactory reporting criteria for the CY 2016 reporting
period. Commenters also expressed that changing the requirements from
the previously finalized satisfactory reporting criteria would reward
those who did not originally report according to the finalized
satisfactory reporting criteria, as well as reduce the standard of
quality that the program was meant to represent.
Response: We appreciate the commenters' feedback on this proposal.
While all of the recommendations and rationale provided were
considered, we are finalizing our proposed modifications to the
previously finalized satisfactory reporting criteria for CY 2016 as
proposed to maintain alignment with MIPS quality reporting
requirements. Based on feedback we received from some stakeholders, we
believe that these modifications will simplify the requirements for
some clinicians, as well as provide consistency with the first year of
MIPS.
Comment: One commenter supported the proposed changes, but
recommended the creation of a hardship exemption to relieve
satisfactory reporters, of any number of measures, from the 2018
downward payment adjustment.
Response: We can appreciate the commenter's recommendation.
However, section 1848(a)(8), (k), and (m) of the Act, which direct us
to create and implement the PQRS, do not provide for a hardship
exemption process, nor did we propose to implement such a process. We
note, however, that individual EPs or group practices may seek an
informal review of their satisfactory reporting or satisfactory
participation determination in accordance with Sec. 414.90(m). For
detailed information about submitting an informal review request,
please refer to the PQRS Payment Adjustment Information Web page at
https://www.cms.gov/;Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/PQRS/Payment-Adjustment-Information.html.
After consideration of the public comments, we are finalizing the
proposal to revise the previously finalized satisfactory reporting
criteria for the CY 2016 reporting period to lower the requirement from
9 measures across 3 NQS domains, where applicable, to only 6 measures
with no domain or cross-cutting measure requirement. Please see Table
21 for a summary of our final policies. We are also finalizing the
revisions at Sec. 414.90(j)(8) and (k)(5) as proposed.
Table 21--Summary of the Finalized Modifications to the Requirements for the 2018 PQRS Payment Adjustment:
Individual Reporting Criteria for the Satisfactory Reporting of Quality Measures Data via Claims, Qualified
Registry, and EHRs and Satisfactory Participation Criterion in QCDRs
----------------------------------------------------------------------------------------------------------------
Satisfactory reporting
Reporting period Measure type Reporting mechanism criteria
----------------------------------------------------------------------------------------------------------------
12-month (Jan 1-Dec 31, 2016)...... Individual Measures... Claims................ Report at least 6 measures,
AND report each measure
for at least 50 percent of
the EP's Medicare Part B
FFS patients seen during
the reporting period to
which the measure applies.
If less than 6 measures
apply to the EP, the EP
must report on each
measure that is
applicable, AND report
each measure for at least
50 percent of the Medicare
Part B FFS patients seen
during the reporting
period to which the
measure applies. Measures
with a 0 percent
performance rate will not
be counted (unless they
are inverse measures where
a lower rate reflects
better performance).
[[Page 53204]]
12-month (Jan 1-Dec 31, 2016)...... Individual Measures... Qualified Registry.... Report at least 6 measures,
AND report each measure
for at least 50 percent of
the EP's Medicare Part B
FFS patients seen during
the reporting period to
which the measure applies.
If less than 6 measures
apply to the EP, the EP
must report on each
measure that is
applicable, AND report
each measure for at least
50 percent of the Medicare
Part B FFS patients seen
during the reporting
period to which the
measure applies. Measures
with a 0 percent
performance rate will not
be counted (unless they
are inverse measures where
a lower rate reflects
better performance).
12-month (Jan 1-Dec 31, 2016)...... Individual Measures... Direct EHR Product or Report at least 6 measures.
EHR Data Submission If an EP's direct EHR
Vendor Product. product or EHR data
submission vendor product
does not contain patient
data for at least 6
measures, then the EP must
report all of the measures
for which there is
Medicare patient data. An
EP must report on at least
1 measure for which there
is Medicare patient data.
12-month (Jan 1-Dec 31, 2016)...... Measures Groups....... Qualified Registry.... No changes.
12-month (Jan 1-Dec 31, 2016)...... Individual PQRS QCDR.................. Report at least 6 measures
measures and/or non- available for reporting
PQRS measures under a QCDR AND report
reportable via a QCDR. each measure for at least
50 percent of the EP's
patients seen during the
reporting period to which
the measure applies. If
less than 6 measures apply
to the EP, the EP must
report on each measure
that is applicable, AND
report each measure for at
least 50 percent of the
EP's patients.
----------------------------------------------------------------------------------------------------------------
b. Group Practices
As discussed previously, although we did not propose to collect any
additional data for the CY 2016 reporting period, we proposed to modify
the satisfactory reporting criteria for the CY 2016 reporting period
for purposes of the 2018 PQRS payment adjustment (82 FR 34101).
Specifically, we proposed to lower the requirement from 9 measures
across 3 NQS domains, where applicable, to only 6 measures with no
domain or cross-cutting measure requirement. For group practices, this
would apply to the following reporting mechanisms: Qualified registry;
QCDR; direct EHR product; and EHR data submissions vendor product. This
proposal would not affect the criteria used to determine whether an
individual EP or group practice has satisfactorily reported for
purposes of avoiding the 2017 PQRS payment adjustment, with the
exception of the criteria applicable to individual EPs and group
practices reporting using the ACO Secondary Reporting Period, as
discussed in section III.F.4. of this final rule.
Table 21 in the proposed rule summarized our proposed modifications
to the previously finalized satisfactory reporting criteria for group
practices to avoid the 2018 PQRS payment adjustment, based on data
previously submitted for the CY 2016 reporting period (82 FR 34101
through 34102). We did not propose to collect any additional data for
the CY 2016 reporting period, as the data submission period for the CY
2016 reporting period has already ended. As summarized in Table 21 of
the proposed rule, the NQS domain requirement would no longer apply (82
FR 34101 through 34102). No changes were proposed for the Web Interface
criteria.
Additionally, as discussed previously, we proposed that individual
EPs and group practices reporting via claims and qualified registry, as
applicable, would no longer be required to report a cross-cutting
measure and that individual EPs and group practices reporting via QCDR
would no longer be required to report an outcome or high priority
measure. We note that what is considered to be a ``high-priority''
measure in PQRS is different from what is considered a ``high-
priority'' measure in MIPS, and we did not propose to align this
requirement with MIPS for the last year of PQRS as this could cause
confusion. Although certain MIPS eligible clinicians are required to
report at least one outcome or other high-priority measure (see Sec.
414.1335(a)(1)(i)), we are also not aligning the PQRS requirements with
that requirement because, although we agree that outcome and high-
priority measures are valuable for reporting, we want to revise the
satisfactory reporting criteria for the last year of PQRS to be less
complex for individual EPs and groups.
Where we proposed to lower the requirement to only 6 measures, if
less than 6 measures apply to the individual EP or group practice, each
measure that is applicable would need to have been reported. We define
``applicable'' to mean measures relevant to a particular individual
EP's or group practice's services or care rendered. As previously
finalized, individual EPs and group practices would continue to be
subject to the MAV process (80 FR 71140 through 71145). The MAV process
seeks to identify clinically similar measures and creates clusters of
measures that can be reported if one of the measures in the cluster is
reported. We would maintain the requirement that each required measure
be reported for at least 50 percent of the individual EP's or group
practice's patients to which the measure applies.
Lastly, for purposes of the 2018 PQRS payment adjustment, Sec.
414.90(j)(9)(viii) currently provides that if the CAHPS for PQRS survey
is applicable to the practice, group practices comprised of 100 or more
EPs that register to participate in the GPRO must administer the CAHPS
for PQRS survey, regardless of the GPRO reporting mechanism selected.
For the reasons discussed previously, we proposed to revise Sec.
414.90(j)(9)(viii) to provide that such group practices may administer
the CAHPS for PQRS survey, regardless of the GPRO reporting mechanism
selected, but are not required to do so. This change would be
consistent with the data submission criteria for the MIPS quality
performance category, under which groups may voluntarily elect to
participate in the CAHPS for MIPS survey (see Sec. 414.1335(a)(3)(i)).
As summarized in Table 21 of the proposed rule (82 FR 34101 through
34102), the previously finalized satisfactory reporting criteria for
group practices
[[Page 53205]]
administering the CAHPS for PQRS survey would continue to apply to
group practices that elected to administer the survey.
Accordingly, we proposed to revise Sec. 414.90(j)(9) and (k)(5)
(82 FR 34102). We believe these proposals will result in fewer group
practices being subject to the 2018 PQRS payment adjustment, and will
impose no additional burden on group practices because this data has
already been submitted to CMS. We requested comment on these proposals.
The following is a summary of the public comments received on these
proposals and our responses:
Comment: The majority of commenters supported our proposal to lower
the requirement from 9 measures across 3 NQS domains, where applicable,
to only 6 measures with no domain or cross-cutting measure requirement
for group practices using the following reporting mechanisms: Qualified
registry; QCDR; direct EHR product; and EHR data submissions vendor
product.
Response: We appreciate these commenters' support and are
finalizing these requirements as proposed.
Comment: A commenter supported the proposed changes but recommended
reopening of the 2016 PQRS submissions.
Response: We are not reopening 2016 PQRS data submissions as it is
technically not feasible while maintaining our program deadlines.
After consideration of the public comments, we are finalizing the
proposed changes as proposed. We refer readers to Table 22 to view a
summary of our final policies. We are also finalizing revisions to
Sec. 414.90(j)(9) and (k)(5) as proposed.
Table 22--Summary of Finalized Modifications to the Requirements for the 2018 PQRS Payment Adjustment: Group
Practice Reporting Criteria for Satisfactory Reporting of Quality Measures Data via the GPRO
----------------------------------------------------------------------------------------------------------------
Group practice Reporting Satisfactory reporting
Reporting period size \4\ Measure type mechanism criteria
----------------------------------------------------------------------------------------------------------------
12-month (Jan 1-Dec 31, 2016).. 25+ EPs.......... Individual GPRO Web Interface.... No changes.
Measures in the
Web Interface.
12-month (Jan 1-Dec 31, 2016).. 25+ EPs that Individual GPRO Web Interface + No changes.
elect CAHPS for Measures in the CMS-Certified
PQRS. Web Interface + Survey Vendor.
CAHPS for PQRS.
12-month (Jan 1-Dec 31, 2016).. 2+ EPs........... Individual Qualified Report at least 6
Measures. Registry. measures AND report
each measure for at
least 50 percent of
the group's Medicare
Part B FFS patients
seen during the
reporting period to
which the measure
applies. If less than
6 measures apply to
the group, the group
practice must report
on each measure that
is applicable, AND
report each measure
for at least 50
percent of the
Medicare Part B FFS
patients seen during
the reporting period
to which the measure
applies. Measures
with a 0 percent
performance rate will
not be counted
(unless they are
inverse measures
where a lower rate
reflects better
performance).
12-month (Jan 1-Dec 31, 2016).. 2+ EPs that elect Individual Qualified The group practice
CAHPS for PQRS. Measures + CAHPS Registry + CMS- must have all CAHPS
for PQRS. Certified Survey for PQRS survey
Vendor. measures reported on
its behalf via a CMS-
certified survey
vendor. In addition,
the group practice
must report at least
3 additional measures
using the qualified
registry AND report
each measure for at
least 50 percent of
the group's Medicare
Part B FFS patients
seen during the
reporting period to
which the measure
applies. If less than
3 measures apply to
the group practice,
the group practice
must report on each
measure that is
applicable, AND
report each measure
for at least 50
percent of the
Medicare Part B FFS
patients seen during
the reporting period
to which the measure
applies. Measures
with a 0 percent
performance rate will
not be counted
(unless they are
inverse measures
where a lower rate
reflects better
performance).
12-month (Jan 1-Dec 31, 2016).. 2+ EPs........... Individual Direct EHR Report 6 measures. If
Measures. Product or EHR the group practice's
Data Submission direct EHR product or
Vendor Product. EHR data submission
vendor product does
not contain patient
data for at least 6
measures, then the
group practice must
report all of the
measures for which
there is Medicare
patient data. A group
practice must report
on at least 1 measure
for which there is
Medicare patient
data.
[[Page 53206]]
12-month (Jan 1-Dec 31, 2016).. 2+ EPs that elect Individual Direct EHR The group practice
CAHPS for PQRS. Measures + CAHPS Product or EHR must have all CAHPS
for PQRS. Data Submission for PQRS survey
Vendor Product + measures reported on
CMS-Certified its behalf via a CMS-
Survey Vendor. certified survey
vendor. In addition,
the group practice
must report at least
3 additional measures
using the direct EHR
product or EHR data
submission vendor
product. If less than
3 measures apply to
the group practice,
the group practice
must report all of
the measures for
which there is
patient data. Of the
additional 3 measures
that must be reported
in conjunction with
reporting the CAHPS
for PQRS survey
measures, a group
practice must report
on at least 1 measure
for which there is
Medicare patient
data.
12-month (Jan 1-Dec 31, 2016).. 2+ EPs........... Individual PQRS QCDR............. Report at least 6
measures and/or measures available
non-PQRS for reporting under a
measures QCDR AND report each
reportable via a measure for at least
QCDR. 50 percent of the
group practice's
patients seen during
the reporting period
to which the measure
applies. If less than
6 measures apply to
the group practice,
the group practice
must report on each
measure that is
applicable, AND
report each measure
for at least 50
percent of the group
practice's patients.
----------------------------------------------------------------------------------------------------------------
4. Accountable Care Organization (ACO) Participants Who Report PQRS
Quality Measures Separately During the Secondary Reporting Period
As discussed in the CY 2017 PFS final rule (81 FR 80441 through
80445), individual EPs and group practices who bill under the TIN of an
ACO participant may report separately from the ACO, if the ACO failed
to report on behalf of such individual EPs or group practices for the
applicable reporting period, during the CY 2016 reporting period for
purposes of the 2017 and 2018 PQRS payment adjustments, as applicable.
Please note that, in accordance with our previously established
policies for the ACO Secondary Reporting Period, our finalized
modifications to the satisfactory reporting criteria for individual EPs
and group practices for the CY 2016 reporting period would apply to
such individual EPs and group practices for purposes of the 2017 PQRS
payment adjustment. We did not receive comments on this aspect of the
proposal. These modifications will not affect the 2017 PQRS payment
adjustment for any other individual EP or group practice.
---------------------------------------------------------------------------
\4\ Please note that the group practice size descriptions have
been revised for greater consistency with our policy of making the
CAHPS for PQRS survey voluntary.
---------------------------------------------------------------------------
5. Physician Compare Downloadable Database--Addition of Value Modifier
(VM) Data
We previously finalized in the CY 2016 PFS final rule (80 FR 71129
through 71130) a decision to publicly report three data points for the
2018 VM based on 2016 data in the Physician Compare downloadable file
in late 2017:
2018 VM quality tiers for cost and quality, based on the
2016 data, noting if the EP or group is high, low, or average on cost
and quality per the VM.
A notation of the payment adjustment received based on the
cost and quality tiers--upward, downward, or neutral--for each EP or
group.
An indication if the EP or group was eligible to but did
not report quality measures to CMS for CY 2016 under PQRS.
In light of the proposals to change the 2016 reporting criteria to
avoid the 2018 payment adjustment for PQRS (see section III.F. of this
final rule) and subsequent VM proposed policies to hold all physician
groups and solo practitioners who met minimum quality reporting
requirements harmless from downward payment adjustments for performance
under quality-tiering for the last year of the program (see section
III.I. of this final rule), and because the revised policies for PQRS
and VM in this rule will change the nature of how the PQRS data will be
used under the VM, we proposed not to report this data specific to the
VM (82 FR 34103). Given the fact that VM data would have been available
for posting in the Physician Compare downloadable database for only 1
year and the VM data may not reflect an EP or group's actual
performance or payment adjustment given they could have chosen to
report fewer measures, we believe that proceeding with the posting of
this data could be confusing for the public.
Additionally, we have created other VM data files intended to
promote transparency. For each VM performance year, we will publish a
Public Use File (PUF) that contains VM performance results of de-
identified practices. Supporting documentation for each PUF contains
the field name, length, type, label, description, and notes for each
variable included in the PUF. The Value Modifier program years 2015 and
2016 (performance year 2013 and 2014) are currently available at
https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/VMPUF/Value-Modifier-PUF.html. In addition, three
Research Identifiable Files (RIFs) for Value Modifier program years
2015 and 2016 (performance year 2013 and 2014) are available through
the Research Data Assistance Center (ResDAC) and will be made available
for each program year. These files include a practice-level, an NPI-
practice level, and a beneficiary-level file, as described at: https://www.resdac.org/news/cms-creates-set-rif-data-files-support-value-based-payment-modifier-program/2017/06.
All other previously finalized policies related to 2016 PQRS data
available for public reporting on Physician Compare in late 2017 remain
unchanged (80 FR 71116 through 71132). Appreciating this, we believe
the best course of action is to not move forward with publicly
reporting this VM data for 2016. All data required to be reported by
law will remain available for public reporting as previously finalized
(80 FR 71116
[[Page 53207]]
through 71132). For more information on the public reporting policies
previously finalized and proposed for MIPS, we refer readers to the
following two rules: The Medicare Program; Merit-Based Incentive
Payment System (MIPS) and Alternative Payment Model (APM) Incentive
Under the Physician Fee Schedule, and Criteria for Physician-Focused
Payment Models final rule with comment period (81 FR 77390 through
77399); and Medicare Program; CY 2018 Updates to the Quality Payment
Program proposed rule (82 FR 30163 through 30170). We requested comment
on this proposal not to move forward with publicly reporting the VM
information in the downloadable database and specifically, if we were
to release this data, how it could be used by the public.
The following is a summary of the public comments received on this
proposal and our responses:
Comment: Almost all commenters who specifically addressed the
proposal not to move forward with reporting the VM data in the
Physician Compare downloadable database supported this proposal.
Overwhelmingly, commenters indicated it would be best not to report
these data, understanding that the policy changes for both PQRS and the
VM changed the nature of the data available for public reporting.
Commenters also noted including these data would be confusing for both
clinicians and patients. And, they also commented that it would be best
not to include these data for just 1 year.
Response: We appreciate the comments received and agree with the
large majority of commenters that indicated these data would
potentially confuse the public and not add significant value given the
changes to the PQRS and VM policies. And, we agree that because this
would be the first and only year the data were available for public
reporting, it is best to not publicly report the information.
Comment: A few commenters opposed this proposal and asked CMS to
move forward with publicly reporting these VM data to support
transparency and specifically so clinicians could get value from the
tiering data.
Some other commenters did question if this type of data was
consistent with the goals of Physician Compare, generally, and others
questioned if this type of data was useful for decision-making. For
transparency purposes, many of these commenters noted the available
aggregated, de-identified data was sufficient.
Response: For transparency purposes, as previously noted, these
data are already available in a PUF that contains VM performance
results of de-identified practices. Clinicians could use the PUF files
to evaluate the tiering information as that is included and already
public. As noted, we agree these data are not the data most likely to
be evaluated by Physician Compare users when looking to make a decision
about their health care. But, we anticipate that the audience for the
downloadable database will be composed primarily of third party data
users, as well as the clinicians and groups themselves, rather than
patients and their caregivers. As a result, we appreciate the comment
regarding usefulness and alignment with Physician Compare goals, but
also note that the primary goal of the downloadable database is to
promote transparency. Again, we believe the PUF file is appropriate for
this purpose.
As a result of the public comments, we are finalizing this
proposal, and, as a result, we will not be including VM data in the
Physician Compare downloadable database related to the 2018 payment
adjustment.
G. Clinical Quality Measurement for Eligible Professionals
Participating in the Electronic Health Record (EHR) Incentive Program
for 2016
1. Background
Sections 1848(o), 1853(l) and (m), 1886(n), and 1814(l) of the Act
provide the statutory basis for the Medicare incentive payments made to
eligible professionals (EPs), Medicare Advantage (MA) organizations
(for certain qualifying EPs and hospitals), subsection (d) hospitals,
and critical access hospitals (CAHs) that demonstrate meaningful use of
certified electronic health record (EHR) technology (CEHRT). Sections
1848(a)(7), 1853(l) and (m), 1886(b)(3)(B), and 1814(l) of the Act also
establish downward adjustments to Medicare payments, beginning with
calendar or fiscal year (FY) 2015, for EPs, MA organizations,
subsection (d) hospitals, and CAHs that are not meaningful users of
CEHRT for certain associated reporting periods. Sections 1903(a)(3)(F)
and 1903(t) of the Act provide the statutory basis for the Medicaid
incentive payments made to EPs and eligible hospitals for the adoption,
implementation, upgrade, and meaningful use of CEHRT. We have
implemented these statutory provisions in prior rulemakings to
establish the Medicare and Medicaid EHR Incentive Programs.
Under these statutory provisions and the regulations at 42 CFR
495.4, one of the requirements of being a meaningful EHR user is
successfully reporting the clinical quality measures selected by CMS to
CMS or the states, as applicable, in the form and manner specified by
CMS or the states, as applicable. Section 1848(o)(2)(B)(iii) of the Act
requires that in selecting clinical quality measures (CQMs) for EPs to
report under the EHR Incentive Program, and in establishing the form
and manner of reporting, the Secretary shall seek to avoid redundant or
duplicative reporting otherwise required, including reporting under
section 1848(k)(2)(C) of the Act (the Physician Quality Reporting
System). As such, we have taken steps to establish alignments among
various quality reporting and payment programs that include the
submission of CQMs.
2. Clinical Quality Measure (CQM) Requirements for Meaningful Use in
2016
Under sections 1848(o)(2)(A)(iii) and 1903(t)(6)(C)(i)(II) of the
Act and the definition of ``meaningful EHR user'' at Sec. 495.4, EPs
must report on CQMs selected by CMS using CEHRT, as part of being a
meaningful EHR user under the Medicare and Medicaid EHR Incentive
Programs. In the final rule titled ``Medicare and Medicaid Programs;
Electronic Health Record Incentive Program--Stage 3 and Modifications
to Meaningful Use in 2015 Through 2017,'' we finalized the options for
CQM submission for EPs in the Medicare EHR Incentive Program in 2016 as
follows (80 FR 62888 through 62889):
EP Options for Medicare EHR Incentive Program
Participation (single program Participation--EHR Incentive Program
only):
++ Option 1: Attest to CQMs through the EHR Registration &
Attestation System.
++ Option 2: Electronically report CQMs through Physician Quality
Reporting System (PQRS) Portal.
EP Options for Electronic Reporting for Multiple Programs
(for example: EHR Incentive Program plus PQRS participation):
++ Option 1: Report individual EP's CQMs through PQRS Portal.
++ Option 2: Report group's CQMs through PQRS Portal.
(Note: Under option 2, this may include an EP reporting using the
group reporting option, either electronically using QRDA, or via the
GPRO Web Interface.)
For the Medicaid EHR Incentive Program, we specified (80 FR 62888)
that states would continue to be responsible for determining whether
and how electronic reporting of CQMs would occur, or if they wish to
allow reporting through attestation. Any
[[Page 53208]]
changes that states make to their CQM reporting methods must be
submitted through the state Medicaid Health IT Plan (SMHP) process for
our review and approval prior to being implemented.
We maintained a requirement that EPs report 9 CQMs covering at
least 3 NQS domains (80 FR 62888 through 62889). This requirement was
established in the final rule titled ``Medicare and Medicaid Programs;
Electronic Health Record Incentive Program--Stage 2'' (77 FR 54058).
We also continued (80 FR 62888 through 62889) our existing policy
that under Medicare, healthcare providers in any year of participation
for the EHR Incentive Program for 2015 through 2017 may electronically
report CQM data using the options previously outlined for electronic
reporting either for single program participation in the Medicare EHR
Incentive Program, or for participation in multiple programs if the
requirements of the aligned quality program are also met.
We noted that an EHR certified for CQMs under the 2014 Edition
certification criteria does not need to be recertified each time it is
updated to a more recent version of the eCQMs (80 FR 62889).
3. CQM Requirements for EPs and Groups Under the Medicare EHR Incentive
Program in 2016
As we discussed in section III.F. in this final rule, since we
finalized these requirements, we have heard from stakeholders through
written communications that EPs and groups have found the previously
finalized reporting criteria for the CY 2016 reporting period to be
complex and had difficulty in understanding the requirements to be a
satisfactory reporter, and these same EPs and groups subsequently
requested that the CQM reporting requirements for EPs and groups
participating in the Medicare EHR Incentive Program in 2016 who chose
to report CQMs electronically through the Physician Quality Reporting
System (PQRS) Portal be aligned with those of the Quality Payment
Program, specifically the Merit-based Incentive Payment System (MIPS).
Therefore, although we did not propose to collect any additional
data for 2016, we proposed to change the reporting criteria for EPs and
groups who chose to electronically report CQMs through the PQRS Portal
for purposes of the Medicare EHR Incentive Program. Specifically, we
proposed to change the reporting criteria from 9 CQMs covering at least
3 NQS domains to 6 CQMs with no domain requirement. We proposed this
change so that the reporting criteria for the Medicare EHR Incentive
Program would be in alignment with the modified requirement that we
proposed for the final PQRS reporting period (2016) in section III.F.
of the proposed rule, as well as the transition year of the Quality
Payment Program. We proposed that an EP or group who satisfies the
proposed reporting criteria may qualify for the 2016 incentive payment
under section 1848(o) of the Act and may avoid the downward payment
adjustment in 2017 and/or 2018 under section 1848(a)(7)(A) of the Act,
depending on the EP or group's applicable EHR reporting period for the
payment adjustment year. This proposed change would help maintain
alignment with PQRS per the requirement under section
1848(o)(2)(B)(iii) of the Act for the Secretary to seek to avoid
redundant or duplicative reporting otherwise required, including
reporting under section 1848(k)(2)(C) of the Act (the PQRS).
We did not propose to change the previously finalized requirements
for CQM reporting in 2016 for eligible hospitals and CAHs; or the
previously finalized requirements for EPs who chose to report CQMs
through attestation in 2016 for the Medicare EHR Incentive Program (80
FR 62888). Our reasoning for not proposing to change the eligible
hospital or CAH requirements for CQM reporting is because the changes
proposed for PQRS in section III.F. of the proposed rule and the
policies established for the transition year of the Quality Payment
Program would only affect clinicians and groups, and therefore, there
is no reason to change the established policy for eligible hospitals or
CAHs. We did not propose to change the requirements for EPs who
reported CQMs through attestation because those who attested were
successful; therefore, we believe there is no need to change the
requirement. Additionally, the Registration and Attestation portal was
phased out on October 1, 2017, and is no longer available for use.
The following is a summary of the public comments received on these
proposals and our responses:
Comment: The majority of commenters supported CMS' proposal to
revise the reporting criteria for EPs for the CY 2016 reporting period,
from 9 measures across 3 NQS domains, to 6 measures with no domain
requirement for EPs and groups who chose to electronically report CQMs
through the PQRS Portal for purposes of the Medicare EHR Incentive
Program in order to align with the changes proposed for PQRS reporting
requirements for 2016.
Response: We appreciate the commenters' support for our proposal.
Comment: One commenter supported the proposed changes but requested
that CMS establish a new ``Administrative Burden'' category of hardship
exception for the 2016 meaningful use reporting period.
Response: We appreciate the commenter's support. We did not
consider or propose any changes to our existing policy on significant
hardship exceptions under the Medicare EHR Incentive Program, and
comments on this topic are outside of the scope of this rulemaking. We
note, however, that for the 2016 program year, we offered multiple
categories of hardship exceptions, covering a number of issues that
participants in the EHR Incentive Program might experience. However,
the application deadline for EPs requesting a hardship exception closed
on July 1, 2017. We also note that the policy we are finalizing
decreases the number of CQMs required for reporting if reported
electronically through the PQRS portal. Given that both the reporting
period and the deadline for submission of applications for a hardship
exception have closed for the CY 2016 reporting year, we are not adding
additional hardship exceptions at this time.
Comment: A few commenters opposed the proposed changes, as time and
resources have already been invested in order to meet the previously
finalized reporting criteria for the CY 2016 reporting period.
Response: We appreciate the commenters' feedback on this proposal
and acknowledge that many EPs have invested time and resources into
meeting the reporting requirements for the CY 2016 reporting period.
Under this proposal, there would be no change in status for those who
successfully met the previously finalized reporting requirements--they
would continue to be successful reporters.
After consideration of the public comments, we are finalizing the
proposal to revise the CQM reporting criteria for EPs from 9 measures
across 3 NQS domains to 6 measures with no domain requirement for EPs
and groups who chose to electronically report CQMs through the PQRS
Portal for purposes of the Medicare EHR Incentive Program in order to
align with the proposed PQRS reporting requirements for 2016. An EP or
group who satisfies these revised reporting criteria (as well as other
EHR Incentive Program requirements) may qualify for the 2016 incentive
payment under section
[[Page 53209]]
1848(o) of the Act and may avoid the downward payment adjustment in
2017 and/or 2018 under section 1848(a)(7)(A) of the Act, depending on
the EP or group's applicable EHR reporting period for the payment
adjustment year.
Lastly, we also did not propose to change the previously finalized
requirements for 2016 for EPs participating in the Medicaid EHR
Incentive Program. At the time that we published the proposed rule, we
had already proposed in ``Medicare Program; Hospital Inpatient
Prospective Payment Systems for Acute Care Hospitals and the Long-Term
Care Hospital Prospective Payment System and Proposed Policy Changes
and Fiscal Year 2018 Rates; Quality Reporting Requirements for Specific
Providers; Medicare and Medicaid Electronic Health Record (EHR)
Incentive Program Requirements for Eligible Hospitals, Critical Access
Hospitals, and Eligible Professionals; Provider-Based Status of Indian
Health Service and Tribal Facilities and Organizations; Costs Reporting
and Provider Requirements; Agreement Termination Notices'' that, for
2017, Medicaid EPs would be required to report on any six CQMs that are
relevant to the EP's scope of practice (82 FR 20135). On August 14,
2017, we finalized that proposal (82 FR 38487). In proposing and
finalizing that change, we indicated that it is our intention to align
CQM requirements for Medicaid EPs with the requirements of Medicare
quality improvement programs, to the extent practicable. However, due
to the timing of this rulemaking and when any proposed changes for 2016
would take effect (if finalized), we were concerned that the benefits
of proposing to extend the policy proposed for Medicare EPs for 2016 to
Medicaid EPs for 2016 would not be realized, and the burden on states
to implement such a policy would be significant. There is no negative
payment adjustment for not participating in the Medicaid EHR Incentive
Program, so we explained that it was likely that applying the proposed
policy for Medicare EPs to Medicaid EPs for 2016 would benefit Medicaid
EPs only if they were able to submit new data to states for a Medicaid
EHR incentive payment for 2016. Because we anticipated that most states
would have completed processing and paying 2016 Medicaid EHR incentive
payments by the time such a proposal (if finalized) would take effect,
we explained that we believed that applying this change to the Medicaid
EHR Incentive Program for 2016 would significantly burden states. We
sought comment on our assessment of the difficulty states might face
implementing this policy for 2016 for Medicaid EPs, and on the number
of Medicaid EPs who might benefit if we instead decided to apply this
policy in the Medicaid EHR Incentive Program for 2016, to the extent
that doing so would be legally permissible.
We did not receive any comments related to our request for comment,
and are not changing the previously finalized CQM reporting
requirements for 2016 for EPs participating in the Medicaid EHR
Incentive Program.
H. Medicare Shared Savings Program
Under section 1899 of the Act, we established the Medicare Shared
Savings Program (Shared Savings Program) to facilitate coordination and
cooperation among health care providers to improve the quality of care
for Medicare Fee-For-Service (FFS) beneficiaries and reduce the rate of
growth in expenditures under Medicare Parts A and B. Eligible groups of
providers and suppliers, including physicians, hospitals, and other
health care providers, may participate in the Shared Savings Program by
forming or participating in an Accountable Care Organization (ACO). The
final rule establishing the Shared Savings Program appeared in the
November 2, 2011 Federal Register (Medicare Program; Medicare Shared
Savings Program: Accountable Care Organizations; Final Rule (76 FR
67802) (hereinafter referred to as the ``November 2011 final rule'')).
A subsequent major update to the program rules appeared in the June 9,
2015 Federal Register (Medicare Program; Medicare Shared Savings
Program: Accountable Care Organizations; Final Rule (80 FR 32692)
(hereinafter referred to as the ``June 2015 final rule'')). A final
rule addressing changes related to the program's financial benchmark
methodology appeared in the June 10, 2016 Federal Register (Medicare
Program; Medicare Shared Savings Program; Accountable Care
Organizations--Revised Benchmark Rebasing Methodology, Facilitating
Transition to Performance-Based Risk, and Administrative Finality of
Financial Calculations (81 FR 37950) (hereinafter referred to as the
``June 2016 final rule'')). We have also made use of the annual
calendar year (CY) Physician Fee Schedule (PFS) rules to address
quality reporting and certain other issues. In addition, in the CY 2017
Quality Payment Program final rule (81 FR 77255 through 77256), we
finalized policies related to the Alternative Payment Model (APM)
scoring standard under the Merit-Based Incentive Payment System (MIPS),
which reduces the reporting burden for MIPS eligible clinicians who
participate in MIPS APMs, such as the Shared Savings Program, by: (1)
Using the same quality data reported by the ACO using the CMS Web
Interface for purposes of the Shared Savings Program to score the MIPS
quality performance category for these eligible clinicians and (2)
automatically awarding MIPS eligible clinicians a minimum of one-half
of the total points in the improvement activities performance category;
and (3) not assessing MIPS eligible clinicians on the cost performance
category because, through their participation in the ACO, they are
already being assessed on cost and utilization under the Shared Savings
Program.
In the CY 2018 PFS proposed rule (82 FR 34105 through 34110), we
proposed two modifications to the Shared Savings Program beneficiary
assignment methodology for performance years beginning on or after
January 1, 2019: (1) Revisions to the assignment methodology under 42
CFR part 425, subpart E to reflect the requirement under section 17007
of the 21st Century Cures Act (Pub. L. 114-255, December 13, 2016),
that the Secretary determine an appropriate method to assign Medicare
FFS beneficiaries to an ACO based on their utilization of services
furnished by rural health clinics (RHCs) or federally qualified health
centers (FQHCs), and (2) addition of new chronic care management (CCM)
and behavioral health integration (BHI) service codes to our definition
of primary care services. In addition, we proposed to revise the
methodology used in our quality measure validation audits and the way
the results of these audits may be used to adjust an ACO's sharing rate
(82 FR 34113 through 34114). We also proposed to reserve the discretion
to redesignate a measure reported through the CMS Web Interface as pay-
for-reporting when substantive changes are made to the measure under
the Quality Payment Program (82 FR 34110 through 34113).
We also addressed proposals intended to reduce application burden
for stakeholders by reducing certain documentation submission
requirements included in the initial Shared Savings Program application
and the application for use of the Skilled Nursing Facility (SNF) 3-Day
Rule Waiver (82 FR 34114 through 34120). We also proposed to establish
specific procedures to address situations where a Taxpayer
Identification Number (TIN) that is an ACO participant in more than one
ACO begins to submit claims for services used in the beneficiary
assignment process and becomes out of
[[Page 53210]]
compliance with the ``exclusivity'' requirement in Sec. 425.306(b)(2)
(82 FR 34120 through 34122). Finally, we proposed that, for performance
year 2018 and subsequent years, we would only include individually
beneficiary identifiable payments made under a demonstration, pilot or
time limited program that are final and not subject to further
reconciliation in financial calculations related to establishing and
updating benchmarks and determining performance year expenditures under
the Shared Savings Program (82 FR 34122 through 34123).
1. Modifications to the Shared Savings Program Beneficiary Assignment
Methodology
a. Assignment of Beneficiaries to ACOs That Include RHCs and/or FQHCs
(1) Background
(a) General Shared Savings Program Assignment Methodology
As originally enacted in the Affordable Care Act, section 1899(c)
of the Act requires us to assign FFS beneficiaries to an ACO
participating in the Shared Savings Program based on the beneficiary's
utilization of primary care services rendered by physicians
participating in the ACO. We refer readers to the CY 2018 PFS proposed
rule (82 FR 34105 through 34108) for an overview of existing policies
for assigning beneficiaries to ACOs under the Shared Savings Program
consistent with the requirements of section 1899(c) of the Act. The
regulations governing the assignment methodology under the Shared
Savings Program are in part 425, subpart E. Briefly, in the November
2011 final rule we adopted a claims-based hybrid approach (called
preliminary prospective assignment with retrospective reconciliation)
for assigning beneficiaries to an ACO (76 FR 67851 through 67870),
which is currently applicable to ACOs participating under Track 1 or
Track 2 of the Shared Savings Program. Under this approach,
beneficiaries are preliminarily assigned to an ACO, based on a two-step
assignment methodology, at the beginning of a performance year and
quarterly thereafter during the performance year, but the final
beneficiary assignment is determined after each performance year based
on where beneficiaries chose to receive a plurality of their primary
care services during the performance year. Subsequently, in the June
2015 final rule, we implemented an option for ACOs to participate in a
new two-sided performance-based risk track, Track 3 (80 FR 32771
through 32781). Under Track 3, beneficiaries are prospectively assigned
to an ACO at the beginning of the performance year using the same two-
step methodology used in the preliminary prospective assignment
approach, based on where the beneficiaries have chosen to receive a
plurality of their primary care services during a 12-month assignment
window offset from the calendar year that reflects the most recent 12
months for which data are available prior to the start of the
performance year. The ACO is held accountable for beneficiaries who are
prospectively assigned to it for the performance year. Under limited
circumstances, a beneficiary may be excluded from the prospective
assignment list during or after the performance year, such as if the
beneficiary enrolls in Medicare Advantage during the performance year
or no longer lives in the United States or U.S. territories and
possessions.
Finally, in the CY 2017 PFS final rule (81 FR 80501 through 80510),
we further enhanced the claims-based beneficiary assignment methodology
by finalizing a policy under which beneficiaries, beginning in
performance year 2017, may designate a ``primary clinician'' they
believe is responsible for coordinating their overall care using
MyMedicare.gov, a secure, online, patient portal. (We would note that
although we previously used the term ``main doctor'' in the CY 2017 PFS
final rule, we are using the more comprehensive term ``primary
clinician'' in this final rule for consistency with MyMedicare.gov and
to reflect that beneficiaries can designate healthcare provider types
other than physicians as responsible for coordinating their overall
care.) Notwithstanding the assignment methodology in Sec. 425.402(b),
beneficiaries who designate an ACO professional whose services are used
in assignment as responsible for their overall care will be
prospectively assigned to the ACO in which that ACO professional
participates, provided the beneficiary meets the eligibility criteria
established at Sec. 425.401(a) and has had at least one primary care
service during the assignment window with an ACO professional in the
ACO who is a primary care physician or a physician with one of the
primary specialty designations included in Sec. 425.402(c). Such
beneficiaries will be added prospectively to the ACO's list of assigned
beneficiaries for the subsequent performance year.
(c) Special Assignment Conditions for RHCs and FQHCs
As we noted in the November 2011 final rule, RHC and FQHC claims
contain very limited information concerning the individual
practitioner, or even the type of health professional (for example,
physician, PA, or NP) who provided the service to the beneficiary
because this information is not necessary to determine payment rates
for services in RHCs and FQHCs (76 FR 67858 through 67861). Therefore,
unlike physician fee schedule claims, there is no direct way for us to
determine if an RHC or FQHC claim was for a service furnished by a
physician at the RHC or FQHC. Despite this difference in claims billing
for RHCs and FQHCs, we established a process that allows primary care
services furnished in RHCs and FQHCs to be considered in the assignment
process for any ACO that includes an RHC or FQHC as an ACO participant.
This process is set forth in Sec. 425.404. The special procedures that
we have established for using RHC and FQHC services in the assignment
methodology are discussed in detail in the June 2015 final rule (80 FR
32755 through 32756). We assign beneficiaries to ACOs that include RHCs
or FQHCs as ACO participants in a manner generally consistent with how
we assign beneficiaries to other ACOs based on primary care services
performed by certain physicians and non-physician practitioners who are
ACO professionals in the ACO. However, to address the requirement under
section 1899(c) of the Act that beneficiaries be assigned to an ACO
based on their use of primary care services furnished by physicians, we
require ACOs that include RHCs or FQHCs to identify, through an
attestation, the physicians that directly provide patient primary care
services in their ACO participant RHCs or FQHCs (see Sec. Sec.
425.204(c)(5)(iii) and 425.404(a)). We use the combination of the RHC
or FQHC ACO participant TIN (and another unique identifier, such as a
CCN, when appropriate) and the NPIs of the RHC or FQHC physicians
provided to us through the attestation process to identify those
beneficiaries who received a primary care service from a physician in
the RHC or FQHC and who are therefore eligible to be assigned to the
ACO.
This required attestation process for submitting physician
identifiers requires more effort to ensure the accuracy of the ACO
participant list (including the attestation that includes the physician
identifiers) than the level of effort required for ACOs that do not
include RHCs and FQHCs. In addition,
[[Page 53211]]
we have recognized that the required attestation process for submitting
physician identifiers is prone to error because some RHCs and FQHCs
(particularly rural FQHCs) have multiple locations with potentially
hundreds of NPIs to report which, in turn, increases the likelihood
that ACOs that include RHCs or FQHCs as ACO participants will make
inadvertent clerical errors, such as transposing digits, in submitting
the required information. Errors that are not identified and corrected
by the specified deadline for additions to the ACO participant list may
result in fewer claims being considered for purposes of determining
eligibility for assignment under the Shared Savings Program than would
otherwise occur.
(2) Proposals
Section 17007 of the 21st Century Cures Act amended section 1899(c)
of the Act (42 U.S.C. 1395jjj(c)) to require the Secretary to assign
beneficiaries to ACOs participating in the Shared Savings Program based
not only on their utilization of primary care services furnished by
physicians but also on their utilization of services furnished by RHCs
and FQHCs, effective for performance years beginning on or after
January 1, 2019. The statute provides the Secretary with broad
discretion to determine how to incorporate services provided by RHCs
and FQHCs into the Shared Savings Program beneficiary assignment
methodology.
As explained in the proposed rule (82 FR 34108), we believe that
the amendments to section 1899(c) made by 21st Century Cures Act enable
us to revise the assignment methodology to address the concerns
expressed by certain stakeholders regarding the burdens placed on ACOs
that include RHCs and FQHCs as ACO participants. Accordingly, in
implementing section 17007 of the 21st Century Cures Act, we indicated
that we believe it would be appropriate to reduce operational burdens
for ACOs that include RHCs or FQHCs as ACO participants and bring
greater consistency to the operational method of using claims to assign
beneficiaries to ACOs. To promote participation of RHCs and FQHCs under
the Shared Savings Program, we proposed to remove the burdensome
attestation requirement and instead treat a service reported on an RHC
or FQHC institutional claim as a primary care service furnished by a
primary care physician for purposes of the step-wise assignment
methodology under 42 CFR part 425, subpart E described in the proposed
rule (82 FR 34105 through 34106). Consistent with the 21st Century
Cures Act, under this proposal: (1) The requirement for an attestation
identifying physicians who directly provide primary care services in
each RHC or FQHC that is an ACO participant and/or ACO provider/
supplier in the ACO would be removed; (2) all RHC and FQHC claims would
be used to establish beneficiary eligibility to be assigned to the ACO;
and (3) all RHC and FQHC claims would be included in step 1 of the
stepwise assignment methodology. We noted that in considering all
services billed under the TIN of the ACO participant RHC or FQHC, we
would include services that do not meet the definition of primary care
services, and such services would not be limited to those provided by a
primary care physician, as defined under program rules. This means that
under the proposal, a beneficiary could be furnished any service in an
RHC or FQHC only by a nurse practitioner, physician assistant, clinical
nurse specialist, or any other practitioner in the RHC or FQHC and
still be eligible for assignment to the ACO in which the RHC or FQHC is
participating.
More specifically, we proposed the following changes to our
regulations: (1) Remove Sec. 425.204(c)(5)(iii) in its entirety; (2)
revise Sec. 425.404; and (3) make conforming changes to the definition
of primary care physician found at Sec. 425.20. Under our proposal,
for performance year 2019 and subsequent performance years, ACOs with
ACO participants that are RHCs and FQHCs would no longer be required to
submit NPIs or other identifying information for physicians who
directly provide primary care services in the ACO participant RHCs and
FQHCs as indicated in Sec. 425.204(c)(5)(iii)(A) and Sec. 425.404(a).
Therefore, we proposed to remove Sec. 425.204(c)(5)(iii) in its
entirety. Additionally, we proposed revisions to Sec. 425.404 to
reflect that for performance year 2019 and subsequent performance
years, we would assign beneficiaries to ACOs based on services
furnished in RHCs or FQHCs consistent with the general assignment
methodology in Sec. 425.402, by treating a service reported on an RHC
or FQHC institutional claim in the same way as a primary care service
performed by a primary care physician. We also proposed to remove
revenue center codes from the definition of primary care services
(Sec. 425.20) for performance year 2019 and subsequent performance
years because all RHC and FQHC services will be used for purposes of
assignment for benchmark and performance years; therefore, it is
appropriate to modify our definition of primary care services for
performance year 2019 and subsequent years to no longer include revenue
center codes. Additionally, because the requirement for an attestation
under Sec. 425.404 is also referenced in the definition of primary
care physician in Sec. 425.20, we proposed to make a conforming
revision to that definition to remove the reference to the attestation
requirement for performance year 2019 and subsequent years.
Consistent with how we have implemented other changes to the
assignment methodology (see, for example, 80 FR 32757 through 32758),
we proposed to adjust all ACO benchmarks at the start of the first
performance year in which the new assignment rules are applied so that
the ACO benchmarks reflect the use of the same assignment rules as will
apply in the performance year. Also, consistent with how we have
implemented previous changes to the Shared Savings Program assignment
methodology, we would use the new methodology each time assignment is
determined for purposes of performance year 2019, including using the
new methodology in late CY 2018 to determine the eligibility of ACOs
wishing to enter into or renew a participation agreement beginning
January 1, 2019.
We sought comments on these proposals. We also invited suggestions
on how we might further support participation of RHCs and FQHCs in the
Shared Savings Program.
Comment: Nearly all commenters strongly supported the proposals,
agreeing that the proposed revisions would decrease administrative
burdens for ACOs that include RHCs and FQHCs as ACO participants. One
commenter indicated support for the proposals only in situations where
the plurality of services is provided by an RHC or FQHC. A few
commenters appreciated the attempt to reduce burden for ACOs that
include RHCs and FQHCs as ACO participants but expressed concerns that
treating all RHC and FQHC claims as primary care services and/or
including certain specialty services furnished by non-physician
practitioners (NPPs) could result in unanticipated beneficiary
assignment results. One of these commenters suggested instituting an
optional attestation process in which RHCs/FQHCs and NPPs could
voluntarily attest they furnish specialty services (and not primary
care services) for purposes of beneficiary assignment and the
exclusivity requirement under Sec. 425.306(b)(2).
Response: We appreciate the supportive comments on these proposals.
We believe these revisions to the assignment methodology will reduce
[[Page 53212]]
administrative burden for ACOs that include RHCs or FQHCs as ACO
participants and support our policy goal of assigning beneficiaries to
the entity that is primarily responsible for the beneficiary's overall
care. Notably, section 1899(c) of the Act, as amended by section 17007
of the 21st Century Cures Act, does not restrict the RHC and FQHC
services that may be used in assignment for performance years beginning
on or after January 1, 2019 to primary care services. Although most
services provided by RHCs and FQHCs are primary care services, in view
of the broad statutory reference in section 1899(c)(2) to RHC and FQHC
``services,'' rather than ``primary care services,'' we believe it is
appropriate to include all services furnished by RHCs or FQHCs to
establish beneficiary eligibility to be assigned to an ACO and in the
stepwise assignment methodology . We recognize the unique needs and
challenges of rural and underserved communities and the key role played
by providers and suppliers serving these communities in assuring access
to health care. RHCs, FQHCs, and other providers furnishing care in
rural and underserved communities play an important role in the
nation's health care delivery system by serving as safety net providers
of primary care and other health care services, and we believe these
changes will enhance their ability to participate in the Shared Savings
Program, while also helping to ensure that a beneficiary is assigned to
an ACO when the ACO participants in that ACO are responsible for the
beneficiary's overall care. We appreciate the additional suggestions on
how to assess NPP claims and will continue to consider whether services
provided in RHCs/FQHCs by NPPs who provide primary care should be
treated differently for purposes of beneficiary assignment than those
provided by NPPs who supplement or support specialty practices.
We are finalizing the revisions to our assignment policies for
services furnished in FQHCs and RHCs as proposed. Specifically, we are
finalizing our proposals to: (1) Remove Sec. 425.204(c)(5)(iii) and
modify Sec. 425.404 to eliminate the requirement, for performance year
2019 and subsequent performance years, for ACOs that include an RHC or
FQHC as an ACO participant to provide an attestation identifying
physicians who directly provide primary care services in each RHC or
FQHC that is an ACO participant and/or ACO provider/supplier in the
ACO, and make conforming changes to the definition of primary care
physician at Sec. 425.20; and (2) for performance year 2019 and
subsequent performance years, to: (a) Treat a service reported on an
RHC or FQHC claim as if it were a primary care service performed by a
primary care physician under the assignment methodology in Sec.
425.402, and (b) remove revenue center codes from the definition of
primary care services.
b. Revisions to the Definition of Primary Care Services
(1) Background
Except as discussed previously in this section of the final rule,
for services furnished by RHCs and FQHCs for performance years
beginning on or after January 1, 2019, section 1899(c) of the Act
requires the Secretary to assign beneficiaries to an ACO ``based on
their utilization of primary care services'' provided by a physician.
We currently define primary care services for purposes of the Shared
Savings Program in Sec. 425.20 as the set of services identified by
the following HCPCS/CPT codes: 99201 through 99215, 99304 through 99318
(excluding claims including the POS 31 modifier), 99319 through 99340,
99341 through 99350, 99495, 99496, 99490, the Welcome to Medicare visit
(G0402), and the annual wellness visits (G0438 and G0439). In addition,
we have established a cross-walk for these codes to certain revenue
center codes used by RHCs and FQHCs (for services furnished prior to
January 1, 2011) so that their services can be included in the
beneficiary assignment process. Lastly, we include G0463 for services
furnished in electing teaching amendment (ETA) hospitals.
(2) Proposals
In the proposed rule (82 FR 34110), we proposed to revise the
definition of primary care services currently located in Sec. 425.20
to include three additional CCM service codes 99487, 99489, and G0506,
and four BHI service codes G0502, G0503, G0504 and G0507, beginning in
2018 for performance year 2019 and subsequent performance years and to
include these codes when performing beneficiary assignment under Sec.
425.402. The three additional CCM codes reflect the changes in medical
practice toward advanced primary care and differ from each other only
in the amount of clinical staff service time provided; the complexity
of medical decision-making as defined in the Evaluation and Management
guidelines (determined by the problems addressed by the reporting
practitioner during the month); and the nature of care planning that
was performed (establishment or substantial revision of the care plan
for complex CCM versus establishment, implementation, revision, or
monitoring of the care plan for non-complex CCM). The BHI codes reflect
important enhancements in primary care to support improvement and
integration of care provided for patients receiving behavioral health
treatment.
In addition, we proposed to move the list of primary care service
codes currently listed in the definition of ``primary care services''
in Sec. 425.20 to Sec. 425.400(c). We believe Sec. 425.400, which
specifies general requirements related to the assignment methodology
and currently contains a cross-reference at Sec. 425.400(c) to the
definition of primary care services under Sec. 425.20, is the more
appropriate place to specify the particular primary care codes that
will be considered in the assignment methodology. We also proposed to
reorganize the list of service codes, grouping HCPCS codes, G codes,
and revenue center codes together, respectively, by relevant
performance year(s). We sought comments on this proposal. In addition,
we sought comments as to whether there are any additional existing
HCPCS/CPT codes that we should consider adding to the definition of
primary care services in future rulemaking for purposes of assignment
of beneficiaries to ACOs under the Shared Savings Program. Finally, we
also proposed to remove paragraph (3) from the definition of primary
care services, rather than move it to Sec. 425.400(c) along with the
other paragraphs making up the definition of primary care services.
Paragraph (3) indicates that we will include additional codes
designated by us as primary care services, including new HCPCS/CPT and
revenue center codes and any subsequently modified or replacement codes
for the HCPCS/CPT and revenue center codes identified in the
definition. We explained that, because we always have the flexibility
to propose these changes through rulemaking, this provision is
unnecessary.
Comment: Nearly all commenters strongly supported this proposal to
add the specified CCM and BHI codes to the definition of primary care
services. However, one commenter disagreed with the proposal to include
CCM as a primary care service, stating that the value of CCM services
is highly disputed in the ACO community and that CCM services are often
provided by outside companies with little connection between the
primary care provider and the beneficiary.
Response: We appreciate the comments supporting our proposed
[[Page 53213]]
changes to the definition of primary care services. We respectfully
disagree with the commenter who believes that value of CCM services is
highly disputed in the ACO community, and note that other commenters,
including ACOs and ACO stakeholders, expressed strong support for the
proposal to add the CCM and BHI codes to the definition of primary care
service. These CCM services are characteristic of the changes in
medical practice toward advanced primary care, and, therefore, we
believe that these services should be considered in determining where a
beneficiary received the plurality of their primary care, and thus in
determining whether an ACO should be responsible for the overall care
of that beneficiary.
Comment: A commenter encouraged CMS to continue to refine the
primary care codes used in assignment ``in a timely manner as codes are
finalized for inclusion in the PFS.'' One commenter recommended that
CMS consider including the advance care planning codes, CPT codes 99497
and 99498, in the definition of primary care services in future
rulemaking.
Response: We appreciate receiving thoughtful suggestions from
stakeholders regarding our assignment methodology and will consider
whether CPT codes 99497 and 99498 or any additional existing HCPCS/CPT
codes should be added to the definition of primary care services in
future rulemaking for purposes of assignment of beneficiaries to ACOs
under the Shared Savings Program.
Comment: One commenter recommended exclusion of the costs of new
codes such as for CCM from the financial settlements of ACOs. The
commenter requested that CMS establish a ``revenue neutral threshold
for the existing codes at the time of the base determination'' so that
billing CCM and other new patient centered care management codes would
not impact the ACO's financial performance.
Response: Section 1899(d)(1)(B) of the Act requires us to consider
all expenditures for Part A and Part B services in determining an ACO's
performance year expenditures. At this time, we are not persuaded by
the commenter's suggestion for the need to adjust expenditures to
account for CCM or other patient care management codes. As previously
discussed in the June 2015 Shared Savings Program final rule (80 FR
32794), we believe that adjusting benchmark and performance year
expenditures for the effect of all policy changes, including coding
changes, would create an inaccurate and inconsistent picture of ACO
spending and may limit innovations in ACOs' redesign of care processes
or cost reduction strategies. Therefore, we will continue to include
the costs associated with all Parts A and B claims for assigned
beneficiaries when determining an ACO's financial performance.
We are finalizing the policies in this section as proposed, except
for the minor corrections to Sec. 425.400(c)(1)(iii) and (iv)
described below. Specifically, we are finalizing our proposals to: (1)
Revise the definition of primary care services currently located in
Sec. 425.20 to include three additional CCM service codes 99487,
99489, and G0506, and four BHI service codes G0502, G0503, G0504 and
G0507, beginning in 2018 for performance year 2019 and subsequent
performance years and to include these codes when performing
beneficiary assignment under Sec. 425.402; (2) move the list of
primary care service codes currently included in the definition of
primary care services in Sec. 425.20 to Sec. 425.400(c); (3)
reorganize the list of service codes, grouping HCPCS codes, G codes,
and revenue center codes together, respectively, by relevant
performance year(s); and (4) remove paragraph (3) from the definition
of primary care services at Sec. 425.20.
Finally, we note that in the proposed rule, we made a typographical
error in the proposed regulatory text for Sec. 425.400(c)(1)(iv).
Consistent with the discussion in the preamble to the proposed rule, we
had intended the listed primary care codes to apply not only ``for
performance year 2019,'' but also for subsequent performance years.''
In addition, in the proposed regulatory text for Sec.
425.400(c)(1)(iii), we inadvertently referenced ``performance year 2017
and 2018'' rather than ``performance years 2017 and 2018.'' We are
making these minor corrections in this final rule.
2. ACO Quality Reporting
a. Changes to the Quality Measure Set Used in Establishing the Quality
Performance Standard
(1) Background
Section 1899(b)(3)(A) of the Act requires the Secretary to
determine appropriate measures to assess the quality of care furnished
by ACOs, such as measures of clinical processes and outcomes; patient
and, wherever practicable, caregiver experience of care; and
utilization, such as rates of hospital admission for ambulatory
sensitive conditions. Section 1899(b)(3)(B) of the Act requires ACOs to
submit data in a form and manner specified by the Secretary on measures
that the Secretary determines necessary for ACOs to report to evaluate
the quality of care furnished by ACOs. Section 1899(b)(3)(C) of the Act
states that the Secretary shall establish quality performance standards
to assess the quality of care furnished by ACOs and seek to improve the
quality of care furnished by ACOs over time by specifying higher
standards, new measures, or both. We designate the quality performance
standard that will apply for each performance year. The quality
performance standard is the overall standard the ACO must meet to be
eligible for shared savings.
In the November 2011 final rule (76 FR 67973), we initially
established a quality performance standard consisting of 33 measures
across 4 domains (see Sec. 425.502(d)), including patient experience
of care, care coordination/patient safety, preventive health, and at-
risk population and a methodology for scoring the measures (see Sec.
425.502(e)). Through the annual rulemaking for the PFS we have reviewed
and updated the quality measures reported by ACOs, including adding new
measures and retiring measures that had become redundant or no longer
met the goals for group reporting, and ensuring that the quality
measures reported by ACOs through the CMS Web Interface align with the
measures reported through the CMS Web Interface by group practices in
other CMS initiatives such as PQRS and the Quality Payment Program. The
quality measure set currently includes 31 quality measures (see Tables
42 and 43 at 81 FR 80488 and 80489). We refer readers to the 2018 PFS
proposed rule for a detailed discussion of ACO quality reporting
requirements and the process we follow under the Shared Savings Program
to account for changes to the quality measure set used in establishing
the quality performance standard (82 FR 34110 through 34111). To avoid
confusion and duplication of rulemaking, and reduce provider burden, we
also finalized a policy in the 2017 PFS final rule that future changes
to the CMS Web Interface measures will be made through rulemaking for
the Quality Payment Program and will be applicable to ACO quality
reporting under the Shared Savings Program (81 FR 80499 and 80500).
Lastly, we finalized a policy in the CY 2016 PFS final rule with
comment period (80 FR 71269) under which we reserve the right to
maintain a measure as pay-for-reporting or revert a pay-for-performance
measure to pay-for-reporting when the measure owner determines the
measure no longer aligns with clinical practice or continued
application of the measure may result in patient harm (see Sec.
425.502(a)(5)).
[[Page 53214]]
(2) Proposals
As previously noted in the background section, we have a policy
that future changes to the CMS Web Interface measures will be adopted
through rulemaking for the Quality Payment Program and will be
applicable to ACO quality reporting under the Shared Savings Program
(81 FR 80501). We also note that, as discussed in the CY 2017 Quality
Payment Program final rule with comment period (81 FR 77136), section
1848(q)(2)(D)(i)(II) of the Act requires the Secretary to update the
final list of quality measures from the previous year (and publish an
updated list in the Federal Register) annually. Updates may include the
removal of quality measures, the addition of new quality measures, and
changes to existing quality measures that the Secretary determines have
gone through substantive changes. In the CY 2017 Quality Payment
Program final rule with comment period, we indicated that in the future
we would use rulemaking for the MIPS program to address substantive
changes to measures (81 FR 77143). On June 20, 2017, we issued a
proposed rule that included proposals to revise certain policies under
the Quality Payment Program for CY 2018, including a proposal to make
substantive changes to several measures reported through the CMS Web
Interface. For example, we proposed substantive changes to the way
performance on ACO-17 Tobacco Use: Screening and Cessation Intervention
is calculated via the CMS Web Interface (see Table E, 82 FR 30469). The
proposed changes would simply revise the measure specifications to
measure the percent of tobacco users that received cessation
counseling; instead of measuring a combined performance rate for
beneficiaries who were screened for tobacco use and for the subset of
beneficiaries who are tobacco users that received tobacco cessation
counseling. In addition, a substantive change was proposed to the
Influenza Immunization measure (ACO-14); however, the changes would
apply only to the Registry and EHR data submission methods and not the
CMS Web Interface reporting method (82 FR 30472). Finally, a
substantive change was proposed for the Body Mass Index Screening and
Follow-Up Plan (ACO-16); specifically, we proposed that the frequency
of documenting BMI would change from 6 to 12 months (82 FR 30471).
Consistent with the way that we have addressed previous changes to
measures, we reviewed the proposed substantive changes to the CMS Web
Interface measures included in the CY 2018 Quality Payment Program
proposed rule to assess whether the changes, if finalized, would
warrant a change in how the measures are used to assess ACO performance
under the Shared Savings Program. As part of this review, we considered
whether the proposed substantive changes might raise sampling issues or
require that we recalculate the measure benchmarks for purposes of the
Shared Savings Program. Based on our review of the Quality Payment
Program proposals and for the reasons discussed in the CY 2018 PFS
proposed rule (82 FR 34112), we did not believe the proposed
``substantive'' changes to the CMS Web Interface measures would require
that we revert these measures to pay-for-reporting for the 2018
performance year. Instead, we indicated that we believe it would be
appropriate under the Shared Savings Program to: (1) Update the measure
specifications through subregulatory guidance in order to continue to
align the measures with the measure specifications used under the
Quality Payment Program and the Million Hearts Initiative, and (2)
retain the current phase-in schedule for the measures rather than
redesignating any of the measures as pay-for-reporting.
However, the statutory directive under the Quality Payment Program
to address substantive changes to measures in rulemaking and the
proposals in the CY 2018 Quality Payment Program proposed rule to
address substantive changes to certain Web Interface measures caused us
to evaluate what recourse we might have in the future under the Shared
Savings Program rules to revert a measure to pay-for-reporting in
instances where a substantive change to the measure makes it
inappropriate to hold ACOs accountable for performance on that measure.
We anticipate that there could be future substantive changes to the CMS
Web Interface measures made under the Quality Payment Program that
would give us reason to redesignate a measure as pay-for-reporting
under the Shared Savings Program. Currently, although the Shared
Savings Program rules afford flexibility to redesignate a measure as
pay-for-reporting when the measure owner determines the measure no
longer aligns with clinical practice or causes patient harm, there is
no discretion to modify how we assess CMS Web Interface measures in the
event substantive changes are made to those measures under the Quality
Payment Program that make it inappropriate to hold ACOs accountable for
performance on the measure. Given the timing of the Quality Payment
Program proposals in relationship to the timing for when the quality
performance benchmarks must be established under the Shared Savings
Program, it may in some cases be necessary to have flexibility to
designate a pay-for-performance measure as pay-for-reporting outside
the formal rulemaking process just before or following the start of a
performance year, consistent with the way in which we have redesignated
measures in the past when measure owners have made changes after the
start of a performance year. Accordingly, we believe it would be
appropriate to modify the Shared Savings Program regulations to provide
additional flexibility to address substantive changes to CMS Web
Interface measures that are made under the Quality Payment Program and
to continue to facilitate alignment of measures with the Quality
Payment Program and other CMS initiatives.
Therefore, we proposed to modify Sec. 425.502(a)(5) to include the
right for CMS to redesignate a measure as pay-for-reporting when a
substantive change to a CMS Web Interface measure is made under the
Quality Payment Program that we determine warrants a change in how the
measure is used to assess ACO performance for purposes of the Shared
Savings Program. This revision would supplement CMS's existing
discretion to redesignate a measure as pay-for-reporting when the
measure owner determines the measure no longer aligns with clinical
practice or causes patient harm. Specifically, we proposed to revise
the regulation at Sec. 425.502(a)(5) to reserve CMS's right to
redesignate CMS Web Interface measures that have undergone a
substantive change as determined under the Quality Payment Program to
pay-for-reporting status. Such measures would not necessarily be
automatically redesignated as pay-for-reporting when a substantive
change occurs (for example, as indicated previously, we do not believe
the substantive changes proposed for 2018 present an impediment to
holding ACOs accountable for performance on these measures in
performance year 2018 and subsequent years); however, in the future,
substantive changes made to CMS Web Interface measures under the
Quality Payment Program (such as when the substantive change to a
measure results in an issue with sampling, calculating performance, or
calculating the quality benchmark) may make it inappropriate to hold an
ACO accountable for performance on the measure for the time needed for
CMS to obtain the information necessary to
[[Page 53215]]
calculate a quality benchmark for the substantively changed measure in
advance of a performance year and/or until ACOs gain experience
reporting the measure, as substantively changed. Although we expect to
conduct at least a preliminary assessment of any substantive changes to
the CMS Web Interface measures as part of the annual PFS rulemaking in
order to determine whether any change to the phase in schedule for a
measure is warranted, because we cannot always anticipate the types of
substantive changes that may occur under the Quality Payment Program or
the effect of those changes on our ability to calculate performance on
the measure, we believed this proposal would provide us with additional
flexibility to redesignate existing measures undergoing a substantive
change as pay-for-reporting on a measure-by-measure basis. We invited
comments on this proposal.
Comment: We received relatively few comments on this proposal.
Those that commented were nearly all supportive. One commenter
supported the proposal, but cautioned CMS that the discretion to revert
a measure to pay for reporting should only be exercised in rare and
necessary circumstances with utmost transparency to the public. One
commenter questioned why CMS is using pay-for-reporting when results-
based incentives help improve population health and requested a
transparent and methodological process that would allow for industry
review and sufficient time to make the related changes.
Response: We appreciate the support for the proposal. Our intent is
to revert measures to pay-for-reporting only in those rare
circumstances where it is necessary to do so to assess ACO quality
performance appropriately. Any use of this discretion will be done with
utmost transparency to ACOs. We believe this additional flexibility
will enable us to more appropriately assess ACO quality performance, by
ensuring that ACOs are not held accountable for performance on a
measure when substantive changes to that measure affect our ability to
assess performance on that measure appropriately. Otherwise, ACOs could
be inappropriately held accountable for performance on such measures
until such time as we could undertake rulemaking to modify the pay-for-
performance status of the measure. During our evaluation of a measure
change, we may determine methods to address that change so that ACOs
can continue to be assessed on their performance on that measure. For
instance, as described in the proposed rule, we evaluated the changes
proposed to the Tobacco Use: Screening and Cessation Intervention in
the CY 2018 QPP proposed rule, and concluded that we still would be
able to use data reported on the measure to establish an appropriate
benchmark that aligns with the updated specifications. As with
redesignations that occur when the measure owner determines a measure
no longer aligns with clinical practice or causes patient harm,
redesignations that occur due to substantive changes to a measure will
be communicated to ACOs as soon as possible through operational
documents and other typical methods we use to communicate with ACOs.
We are finalizing this amendment to our regulations as proposed.
Specifically, we are modifying Sec. 425.502(a)(5) to include the right
for us to redesignate a measure as pay-for-reporting when a substantive
change to a CMS Web Interface measure that is used to assess quality
performance for the Shared Savings Program is made under the Quality
Payment Program.
b. Further Refining the Process Used To Validate ACO Quality Data
Reporting
(1) Background
In the November 2011 final rule, we adopted a regulation at Sec.
425.500(e) under which we retained the right to audit and validate the
quality measure data ACOs submit through the CMS Web Interface (76 FR
67893 through 67894). Under this original validation process, we
selected a subset of CMS Web Interface measures and a random sample of
30 confirmed and completely reported beneficiaries for each measure in
the subset. The ACO was required to provide medical records to support
the data reported in the CMS Web Interface for those beneficiaries. A
measure-specific audit performance rate was then calculated using a
multi-phased audit process. If, at the conclusion of the third phase of
the audit, there was a discrepancy greater than 10 percent between the
quality data reported and the medical records provided during the
audit, the ACO was not given credit for meeting the quality target for
any measure(s) for which the mismatch rate existed.
In the CY 2017 PFS final rule (81 FR 80489 through 80492), we
revisited the Quality Measures Validation audit process and finalized
four improvements to our audit process that addressed the number of
records to be reviewed per measure, the number of audit phases, the
calculation of an audit match rate, and the consequences if the audit
match rate falls below 90 percent. Under the revised process, we will
audit enough medical records to achieve a 90 percent confidence
interval; conduct the audit in a single phase; and calculate an overall
audit match rate. If at the conclusion of the audit process the overall
match rate between the quality data reported and the medical records
provided by the ACO is less than 90 percent, absent unusual
circumstances, we will adjust the ACO's overall quality score
proportional to the ACO's audit performance. The audit-adjusted quality
score is calculated by multiplying the ACO's overall quality score by
the ACO's overall audit match rate. For example, if an ACO's quality
score is 75 percent and the ACO's audit match rate is 80 percent, the
ACO's audit-adjusted quality score would be 60 percent. The audit-
adjusted quality score is the quality score that will be used to
determine the percentage of any earned savings that the ACO may share
or the percentage of any losses for which the ACO is accountable. Under
the revised audit methodology, our intent was to continue to audit a
subset of ACOs, which we would identify by looking for data anomalies
such as high skip rates, although we retained the flexibility to
randomly select ACOs or specific measures for audit as we have done in
the past. We also finalized a new requirement at Sec. 425.500(e)(3)
that an ACO that has an audit match rate of less than 90 percent may be
required to submit a corrective action plan (CAP) under Sec. 425.216
for our approval. In addition, we noted that we would maintain the
right, as described in Sec. 425.500(f), to terminate or impose other
sanctions on any ACO that does not report quality data accurately,
completely, or timely. These new policies applied to quality validation
audits beginning in 2017 with the audits of quality reporting for the
2016 performance year.
(2) Proposals
Since publication of the CY 2017 PFS final rule, we have gained
additional experience with the Quality Measures Validation audits, and
have performed additional analyses related to these audits. Our
analysis of the 2016 Quality Measures Validation audit results for
Shared Savings Program ACOs indicates that the average match rate of
ACOs audited in calendar year 2016 was 72 percent and the median
performance was 80 percent. Typically, during the audit, we review
medical record documentation and work with ACOs to better understand
the mismatch between what was reported and what was documented and have
determined through our analyses that ACOs continue to experience
challenges in understanding certain aspects of the
[[Page 53216]]
measure specifications, coordinating collection of information across
many different providers and practices, and satisfying the requirements
for supporting documentation. Many of these errors are not indicative
of poor quality of care but rather reflect minor errors in process or
in understanding measure requirements. For instance, we have identified
errors by individuals abstracting data from the medical record. In one
case, a medical record abstractor incorrectly misinterpreted the less
than symbol (<) in the quality measure specifications for the ACO-31
Heart Failure: Beta Blocker Therapy for Left Ventricular Systolic
Dysfunction and ACO-33 Angiotensin-Converting Enzyme (ACE) Inhibitor or
Angiotensin Receptor Blocker (ARB) Therapy, and therefore, abstracted
the data incorrectly for reporting.
Under our newly finalized single-phase approach to quality measure
validation audits, minor errors are more likely to affect the final
audit results and impact the calculation of shared savings or shared
losses when the overall match rate is below 90 percent. Additionally,
we note that the match rate threshold under the Hospital Inpatient
Quality Reporting (HIQR) Program is 75 percent. The HIQR validates data
submitted by hospitals, which are entities that generally have more
experience with quality reporting, greater health record accessibility
and integration, and a longer history of validation of quality data
submitted to CMS.
As we stated in the proposed rule, in light of our analyses of the
2016 Quality Measures Validation audit results, we believe it is
appropriate to consider making additional modifications to our Quality
Measures Validation audit process. First, we are concerned that the 90
percent match rate adopted in CY 2017 PFS final rule may be too high
and could inappropriately penalize ACOs that make quality data
reporting errors that are unrelated to care quality. In the early years
of phasing in this new audit methodology, we believe that the match
rate should instead be based on actual ACO experience in order to focus
on holding ACOs accountable for clinically related mismatches in
reporting quality measures as they continue to gain experience with how
to measure, report and improve quality under the program. We believe
that basing the audit match rate threshold on actual Quality Measures
Validation audit results would strike an appropriate balance between
ensuring the accuracy of ACO quality reporting while not unduly
penalizing ACOs for minor quality reporting errors that are not
necessarily indicative of poor quality of care. Accordingly, we believe
it would be appropriate to set the audit match rate threshold based on
the median match rate (80 percent) for ACOs audited in calendar year
2016 rather than an alternative approach such as the mean match rate
because the median match rate would be less affected by data outliers.
Therefore, we proposed to revise Sec. 425.500(e)(2) to indicate that
if an ACO has a match rate below 80 percent, absent unusual
circumstances, we would adjust the ACO's overall quality score
proportional to the ACO's audit performance.
Second, we proposed to amend the method by which we adjust an ACO's
overall quality score to reflect the ACO's audit performance.
Specifically, we proposed to revise the methodology described in the
2017 PFS final rule (81 FR 80490) under which the audit-adjusted
quality score is calculated by multiplying the ACO's overall quality
score by the ACO's audit match rate. Instead, we proposed that for each
percentage point difference between the ACO's match rate and the match
rate considered passing the audit, the ACO's overall quality score
would be adjusted downward by 1 percent. That is, if we finalize the
proposal to establish an 80 percent match rate as the threshold for
passing the Quality Measures Validation audit, and the ACO's match rate
is 75 percent, then under this proposal we would adjust the ACO's
overall quality score downward by 5 percent. To illustrate, assuming a
match rate threshold of 80 percent, an ACO with an overall quality
score of 90 percent would have an audit-adjusted quality score of 85.50
percent, that is, (90-[.05 x 90]) = 85.50.
Finally, we proposed a conforming change to Sec. 425.500(e)(3) to
reflect the 80 percent threshold such that if at the conclusion of the
audit process CMS determines there is an audit match rate of less than
80 percent, the ACO may be required to submit a CAP.
We invited comment on the proposed refinements to the process used
to validate ACO quality data reporting and to adjust an ACO's overall
quality score to reflect the ACO's audit performance. We also sought
comment on an alternative approach we considered to address the Quality
Measures Validation audit match rate and the resulting impact on an
ACO's overall quality score. Consistent with the approach used under
the HIQR program, we considered revising Sec. 425.500(e)(2) to provide
that we would adjust the ACO's overall quality score if an ACO has a
match rate below 75 percent. We did not propose this approach because
the median match rate for the Quality Measures Validation audits
conducted in calendar year 2016 was 80 percent, suggesting that a match
rate of 75 percent may be too low for ACOs.
Comment: Nearly all commenters were supportive of our proposals to
make additional modifications to our quality measure validation audit
process. Commenters stated that the proposal to lower the threshold for
passing the quality validation audit to an 80 percent match rate would
be more in line with hospital quality reporting audit rates and would
be more reasonable, given the current state of documentation in
clinical records. A few commenters suggested that an audit match rate
of no higher than 70 percent would be appropriate to ensure that only
practices with true care quality issues would be targeted for an audit.
One commenter stated that a match rate of 80 percent seems high for the
first year given that the average match rate for the audit that
occurred in CY 2016 was 72 percent. The commenter instead recommended a
phased-in approach, for example, 75 percent in year 1, 77 percent in
year 2 and 80 percent in year 3. One commenter disagreed with reducing
the audit match rate, believing that reducing the match rate would
reduce both the accuracy and integrity of ACO performance assessment.
Response: We do not believe it would be necessary or appropriate to
establish a match rate of less than 80 percent because the results of
the Quality Measures Validation audits conducted on Shared Savings
Program ACOs in calendar year 2016 yielded a median match rate of 80
percent, suggesting that a lower match rate percent may be too low. The
median match rate indicates that at least half of the audited ACOs
achieved a match rate equal to or greater than 80 percent. We did not
propose any changes to our methodology for identifying ACOs for audit,
as stated earlier, we would identify ACOs for audit by looking for data
anomalies such as high skip rates. Additionally we have retained the
flexibility to randomly select ACOs or specific measures for audit. We
also note that over time, we expect ACOs will become more experienced
with the quality reporting requirements, improve their quality
reporting processes and become better clinically integrated. In
addition, because the audit process involves the exchange of
information regarding medical record review and communication between
ACOs and us, the audit process, itself, provides additional education
on the quality measures and quality reporting. As a result, we expect
that in the future, quality validation audit results that show a
significant mismatch between
[[Page 53217]]
the information reported and the underlying medical records will more
consistently reflect meaningful, clinically related quality reporting
errors for which ACOs should be held accountable. Accordingly, we will
periodically review the audit match threshold and seek to increase the
match rate over time.
Comment: A commenter requested that CMS institute rigorous
independent validation and verification procedures to ensure accuracy
and completeness of self-reported data. The commenter recommended that
such validation should be conducted by third-party organizations in a
manner similar to current requirements for Medicare Advantage plans and
other government healthcare programs.
Response: Since the inception of the Shared Savings Program, we
have worked with an independent contractor to conduct the Quality
Measures Validation audit. The organization currently contracted to
conduct the audit is a CMS Quality Innovation Network-Quality
Improvement Organization, and the individuals leading the audit from
this organization have many years of experience doing medical record
review and provide us with an independent assessment of the accuracy of
the data entered into the CMS Web Interface by audited ACOs.
Comment: We also received a number of additional suggestions about
policies that were established in prior rulemaking. For example, a few
commenters expressed concerns about the CMS policy to adjust an ACO's
overall quality score based on the ACO's audit performance. One of
these commenters believes CMS over-weights the measures reported
through the CMS Web Interface to the detriment of CG-CAHPS and claims-
based measures. Another commenter believes that adjusting quality
scores downward to reflect audit performance is unfair and provides no
recourse for ACOs. A commenter suggested that further reductions in the
earned quality score could be problematic given that a significant
number of the existing measures require performance at or above 90
percent in order to earn the maximum points available for the measure.
Response: We thank the commenters for their thoughtful suggestions
on possible ways we might further improve policies and/or operations
related to the Quality Measures Validation audits and related
adjustments to ACOs' overall quality scores. We will consider these
issues further and may address these suggestions in future rulemaking
and/or through guidance documents. We would emphasize, however, that we
continue to believe it is appropriate to adjust an ACO's overall
quality score based on the ACO's audit performance. The audit adjusted
quality scores allow us to use more accurate information in the
reconciliation of the ACO's performance for the prior year. The
accuracy of an ACO's quality reporting is very important, as reflected
in the requirement that ACOs completely and accurately report in order
to be eligible to share in savings. We also continue to believe that
the weights assigned to measures reported through the CMS Web Interface
are appropriate relative to the weights assigned to CG-CAHPS and
claims-based measures. The CMS Web Interface measures make up
approximately one-half of the quality measure set and represent a
number of clinically important concepts in the Preventive Health and
At-Risk Population domains. The CAHPS for ACOs measures are used to
calculate the Patient/Caregiver Experience domain and the claims-based
measures are included in the Care Coordination/Patient Safety domain.
Because the 4 measure domains that comprise the quality score are
equally weighted, performance on the CMS Web Interface measures in the
Preventive Health and At-Risk Population domains determines half of the
ACO's overall quality score. Lastly, while many measures do require
performance at or above 90 percent in order to earn the maximum points
available for the measure, as one commenter pointed out, ACOs can earn
points on measures as long as they perform at or above the minimum
attainment level of 30 percent or the 30th percentile of the benchmark
for the measure.
Comment: A commenter requested a general estimate of the increase
in the number of charts that will be required to attain a 90 percent
confidence interval.
Response: As described in the 2017 PFS final rule (81 FR 80489
through 80492), we do not expect that more than 50 records would be
requested per audited measure to achieve a high level of confidence
that the audited sample is representative of the ACO's quality
reporting performance. We are not seeking to increase the number of
records that would need to be audited at this time.
We are finalizing the policies for ACO Quality Measure Validation
audits in this section as proposed. Specifically, we are finalizing our
proposals to: (1) Revise Sec. 425.500(e)(2) to indicate that if an ACO
has a match rate below 80 percent, absent unusual circumstances, we
will adjust the ACO's overall quality score proportional to the ACO's
audit performance; (2) revise the methodology used to calculate an
ACO's audit-adjusted quality score to provide for a one percent
reduction to the ACO's overall quality score for each percentage point
difference between the ACO's audit match rate and the 80 percent match
rate; and (3) making a conforming change to Sec. 425.500(e)(3) to
reflect the 80 percent match rate.
3. Reducing Shared Savings Program Application Burden
a. SNF 3-Day Rule Waiver Application Requirement That ACOs Report Their
Financial Relationships
(1) Background
The Medicare SNF benefit is for beneficiaries who require a short-
term intensive stay in a SNF, requiring skilled nursing or skilled
rehabilitation care, or both. Under section 1861(i) of the Act,
beneficiaries must have a prior inpatient hospital stay of no fewer
than 3 consecutive days in order to be eligible for Medicare coverage
of inpatient SNF care. In the June 2015 final rule (80 FR 32804 through
32806, 32808), we provided ACOs participating in Track 3 with
additional flexibility to attempt to increase quality and decrease
costs by allowing these ACOs to apply for a waiver of the SNF 3-day
rule to permit their prospectively assigned beneficiaries to receive
coverage for inpatient SNF care without a prior 3-day inpatient
hospital stay when they are admitted to a ``SNF affiliate,'' that is, a
SNF with which the ACO has executed a SNF affiliate agreement, and
certain additional eligibility criteria are met (see Sec.
425.612(a)(1)). All other provisions of the statute and regulations
regarding Medicare Part A post-hospital extended care services continue
to apply. To qualify to use the SNF 3-day rule waiver, ACOs must submit
a SNF 3-Day Rule Waiver application that includes supplemental
information sufficient to demonstrate that the ACO has the capacity to
identify and manage beneficiaries who would be either directly admitted
to a SNF or admitted to a SNF after an inpatient hospitalization of
fewer than 3 days. Required application materials and other program
rules are discussed in detail in the 2018 PFS proposed rule (82 FR
34114 through 34115). We began accepting SNF 3-Day Rule Waiver
applications in the summer of 2016 and approved 26 Track 3 ACOs to
begin using the SNF 3-day rule waiver under the Shared Savings Program
effective January 1, 2017.
[[Page 53218]]
(2) Proposal
As discussed in the proposed rule, the SNF 3-day rule waiver
requirements are primarily based on criteria previously developed under
the Pioneer ACO Model. As explained in the proposed rule, as a result
of our recent experience implementing the waiver in the Next Generation
ACO Model and the Shared Savings Program, we believe that the rules
governing use of the SNF 3-day rule waiver are generally reasonable.
However, based on our initial experiences in reviewing SNF 3-Day Rule
Waiver applications, we believe there are two requirements, in
particular, that impose an unnecessary burden on applicants, without a
sufficient benefit to the administration of the Shared Savings Program.
First, the requirement under Sec. 425.612(a)(1)(i)(A)(4) that an
ACO submit, as part of its application for the SNF 3-day rule waiver, a
narrative describing any financial relationships that exist between the
ACO, SNF affiliates, and acute care hospitals is burdensome for ACOs
and CMS. As explained in the June 2015 final rule (81 FR 32806), the
SNF 3-day rule waiver only provides for coverage of SNF services that
meet all applicable requirements except the requirement for a prior 3-
day inpatient stay. The waiver does not protect financial or other
arrangements between or among ACOs, ACO participants, ACOs providers/
suppliers, or other individuals or entities providing services to
Medicare beneficiaries from liability under the fraud and abuse laws or
any other applicable laws (Sec. 425.612(e)(1)). The Shared Savings
Program regulations do not prohibit ACOs or SNFs from having financial
arrangements with acute care hospitals, nor do they require such
arrangements. Therefore, we have found that the narratives are not
useful to us for purposes of determining whether to approve a waiver
request. Based on our experience with the implementation of SNF 3-day
rule waivers, we proposed to remove the requirement at Sec.
425.612(a)(1)(i)(A)(4) under which an ACO applying for the SNF 3-day
rule waiver must submit a narrative describing any financial
relationships between the ACO, SNF affiliate, and acute care hospitals.
Removing this requirement would not only reduce burden for ACOs
applying for the waiver but would also enable us to devote our
application review resources to a rigorous review of other, more
relevant application elements. Focusing our resources on the review of
the information that is most directly relevant to determining an ACO's
capacity to manage beneficiaries who are admitted to a SNF without a
prior 3-day inpatient hospital stay, along with ongoing oversight and
program compliance monitoring of the use of the waiver by approved ACOs
(as described in section III.G.3.a.(1) of the proposed rule) would also
allow us to more efficiently use our resources to ensure that the SNF
3-day rule waiver is being used appropriately and to address any
potential concerns about use of the waiver. Although we do not believe
it is necessary for ACOs to submit separate narratives describing their
financial relationships for purposes of the SNF 3-day rule waiver, in
the proposed rule we noted that under the Shared Savings Program
regulations, ACOs, ACO participants, ACO providers/suppliers, and other
individuals or entities performing functions or services related to ACO
activities, including SNF affiliates, must maintain and give us access
to certain documents and information related to items including
financial arrangements related to ACO activities (Sec. 425.314(b)(1)).
We also retain broad discretion under Sec. 425.316 to audit ACOs, ACO
participants, and ACO providers/suppliers for compliance with program
rules, and the program rules also make clear that waivers under Sec.
425.612 do not protect financial or other arrangements between or among
ACOs, ACO participants, ACO providers/suppliers, or other individuals
or entities providing services to Medicare beneficiaries or otherwise
limit liability under the fraud and abuse laws or any other applicable
laws (Sec. 425.612(e)).
Second, as explained in the proposed rule, we believe that the
requirement under Sec. 425.612(a)(1)(i)(C) that an ACO submit
documentation demonstrating that each SNF included on its list of SNF
affiliates has an overall rating of 3 or higher under the CMS 5-star
Quality Rating System is unnecessarily burdensome. In order to meet
this requirement, ACOs typically submit a screen shot from the CMS
Nursing Home Compare Web site or other Nursing Home Compare information
that reflects the star rating for each listed SNF. The submission of
this documentation by the ACO does not add value to our review and
approval of SNFs included on the ACO's SNF affiliate list. Instead, we
obtain the information directly from our CMS Nursing Home Compare Web
site during the application review process. In this way, we ensure that
the most current information is used during the application review
process. We also periodically monitor this information after an ACO has
been approved to use the waiver because SNF affiliates are required to
maintain an overall rating of 3 stars or higher, under Sec.
425.612(a)(1)(iii)(A). Because we can obtain the required information
directly from the CMS Nursing Home Compare Web site, the additional
documentation submitted by the ACO as part of its application does not
add value to our ability to review and approve SNF affiliates.
Accordingly, we proposed to eliminate this documentation submission
requirement by removing Sec. 425.612(a)(1)(i)(C).
We sought comments on our proposed changes to the application
requirements for the SNF 3-day rule waiver. We also welcomed other
suggestions on how we might further decrease the burden for ACOs
requesting approval to use the SNF 3-day rule waiver, without
compromising our ability to ensure that ACOs and their SNF affiliates
have the capacity to identify and manage beneficiaries receiving
covered SNF services pursuant to the waiver.
Comment: Commenters uniformly supported these proposals. One
commenter suggested eliminating the waiver application to reduce
burden, and making the waiver available to all ACOs. A few commenters
were supportive of the proposed changes to the waiver application but
recommended that CMS ensure it has the resources to assess and monitor
compliance with the requirement that SNF affiliates have and maintain
at least a 3-star rating. One commenter encouraged CMS to reinforce in
the final rule that the requirement for ACO SNF affiliates to have at
least a 3-star rating is unchanged. In contrast, a few commenters
recommended elimination of the requirement that SNF affiliates have and
maintain at least a 3-star rating. For example, one commenter indicated
that the requirement that SNF affiliates have and maintain at least a
3-star rating may impede beneficiary access or require beneficiaries to
receive care at a SNF facility that is a greater distance from their
family than a closer SNF facility that does not have at least a 3-star
rating. A few commenters had recommendations related to CMS'
methodology for determining star ratings. For example, one commenter
suggested that CMS examine the star rating system, generally, to ensure
appropriate risk adjustment is incorporated into the scoring
methodology.
Response: We appreciate the comments in support of these proposals.
As we stated in the June 2015 final rule (80 FR 32805), we believe
incorporating the requirement that a SNF affiliate have
[[Page 53219]]
an overall rating of 3 or higher under the CMS 5-star Quality Rating
System into the SNF 3-day rule waiver under the Shared Savings Program
provides beneficiaries with evidence that the SNF affiliate provides
quality care. As part of the application process, we intend to continue
to verify that the ACO and its SNF affiliates meet all requirements
related to the SNF 3-day rule waiver, but we believe that the
burdensome and duplicative submission of CMS 5-star Quality Rating
System documentation is not necessary to ensure compliance with the
requirement that the ACO's SNF affiliates have a star rating of 3 or
more. We emphasize that we are not removing or modifying the
requirement in Sec. 425.612(a)(1)(iii)(A) that SNF affiliates must
have and maintain an overall rating of 3 or higher under the CMS 5-star
Quality Rating System to remain eligible to partner with an ACO for
purposes of the SNF 3-day rule waiver; we retain the requirement for
SNF affiliates to have and maintain a 3-star or higher rating.
Suggested changes to the methodology that we use for scoring facilities
on Nursing Home Compare are outside the scope of this final rule though
we intend to share these comments with the appropriate component within
CMS.
Comment: We received several comments that did not directly address
the proposals in this section but were more generally related to the
SNF 3-day rule waiver. For example, one commenter expressed concerns
that beneficiaries do not always know whether and when the ``standard''
SNF 3-day rule applies to them or if it has been waived because of
their assignment to an eligible ACO.
Response: We thank the commenters for their thoughtful suggestions
on possible ways we might further improve policies and/or operations
related to informing beneficiaries regarding the requirements for
coverage of SNF services and any applicable waiver of the SNF 3-day
rule. We will consider these issues further and may address these
suggestions in future rulemaking and/or through guidance documents.
We are finalizing the changes to the SNF 3-Day Rule waiver
application procedures in this section as proposed. We are removing
Sec. 425.612(a)(1)(i)(A)(4), which requires SNF 3-Day Rule Waiver
applicants to submit a narrative describing any financial relationships
that exist between the ACO, SNF affiliate, and acute care hospitals. We
are also finalizing our proposal to remove Sec. 425.612(a)(1)(i)(C),
which requires an ACO applying for the waiver to submit documentation
demonstrating that each SNF affiliate on its SNF affiliate list has an
overall rating of 3 or higher under the CMS 5-star Quality Rating
System.
b. Modifications to the Shared Savings Program Initial Application
(1) Background
In order to participate in the Shared Savings Program,
organizations must meet certain eligibility requirements, including the
statutory requirement to define processes to promote evidence-based
medicine and patient engagement, report on quality and cost measures,
and coordinate care. Additionally, the ACO must demonstrate it meets
patient-centeredness criteria specified by the Secretary, such as the
use of patient and caregiver assessments or the use of individualized
care plans. We discussed and finalized details for ACO eligibility
criteria, including the four required processes and patient-
centeredness criteria, in the November 2011 final rule (76 FR 67826 and
67827) and made updates to them in the June 2015 final rule (80 FR
32722 through 32725). Section 425.204(c)(1) articulates the supporting
documents and materials an ACO must submit to demonstrate that the ACO
satisfies the eligibility requirements to participate in the Shared
Savings Program.
To obtain a determination regarding whether an ACO meets the
requirements to participate in the Shared Savings Program, a
prospective ACO must submit a complete application in the form and
manner required by us by the deadline established by us (Sec.
425.202(a)(1)). The content of the application is outlined at Sec.
425.204. Section 425.204(c) states that as part of the application, and
upon request thereafter, an ACO must submit to us certain supporting
documentation to demonstrate that the ACO satisfies the requirements of
the Shared Savings Program. The supporting documentation required to be
included in the application is discussed in detail in the proposed rule
(82 FR 34116 through 34117).
Once an applicant has submitted the information required under
Sec. 425.204, we evaluate it to determine whether the applicant
satisfies the Shared Savings Program requirements. We notify ACO
applicants during the application review process when information is
missing or when supplemental documentation or other information is
necessary to make a determination on the ACO's application and provide
opportunities for the ACO to submit the requested additional
information for review. At the end of the application review process,
we approve or deny the application and notify the ACO of our
determination.
(2) Proposals
In conducting Shared Savings Program application reviews, we have
found that many of the document submission requirements in Sec.
425.204(c)(1) substantially increase application and review burden
without lending significant value to our review of an organization's
application to confirm that the ACO meets the eligibility requirements
for participation in the Shared Savings Program. We believe it would
meet program needs and reduce applicant burden if we were to revise
Sec. 425.204(c)(1) to remove the requirement to submit supporting
documents or narratives and instead provide that we may request these
materials if additional information is needed in order to fully assess
the ACO's application before making a decision to approve or deny the
application.
To illustrate, as discussed in the proposed rule, we require under
Sec. 425.204(c)(1)(ii), as part of the application process, that the
ACO submit documentation addressing the required processes and patient
centeredness criteria under Sec. 425.112. This requirement is
addressed in the Medicare Shared Savings Program Initial Application
through the requirement that an applicant ACO submit narratives
describing how it will define, establish, implement, evaluate, and
periodically update each process (see application on the CMS Web site
at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/for-acos/application-types-and-timeline.html). In
these narratives, the ACO must also describe certain additional details
regarding the required processes:
Process to promote evidence-based medicine. The ACO must
describe how it will:
++ Encourage the use of protocols grounded in evidence-based
medicine in the case of diagnoses with significant potential for the
ACO to achieve quality improvements, while taking into account the
circumstances of individual beneficiaries; and
++ Use the internal assessments of this process to continuously
improve the ACO's care practices.
Process to promote beneficiary engagement. The ACO must
describe how it will:
++ Evaluate the health needs of its assigned beneficiary population
(including consideration of diversity in its patient population) and
develop a
[[Page 53220]]
plan to address the needs of its population;
++ Communicate clinical knowledge/evidence-based medicine to
beneficiaries in a way they can understand;
++ Engage beneficiaries in shared decision-making in ways that
consider beneficiaries' unique needs, preferences, values and
priorities;
++ Establish written standards for beneficiary access and
communication as well as a process for beneficiaries to access their
medical records; and
++ Use the internal assessments of this process to continuously
improve the ACO's care practices.
Process to internally report quality and cost metrics. The
ACO must describe:
++ How the ACO will use these results to improve care and service
over time; and
++ How the ACO will use the internal assessments of this process to
continuously improve the ACO's care practices.
Process to promote coordination of care. The ACO must
describe:
++ The ACO's methods and processes to coordinate care throughout an
episode of care and during care transitions, such as discharge from a
hospital or transfer of care from a primary care physician to a
specialist (both inside and outside the ACO).
++ The ACO's individualized care program, along with a sample
individual care plan, and explain how the ACO uses this program to
promote improved outcomes for, at a minimum, high-risk and multiple
chronic-condition patients.
++ How individual care plans take into account the community
resources available to beneficiaries.
++ Additional target populations that would benefit from
individualized care plans.
++ How the ACO will use the internal assessments of this process to
continuously improve the ACO's care practices.
++ How the ACO will encourage and promote use of enabling
technologies for improving care coordination for beneficiaries.
++ How the ACO intends to partner with long-term and post-acute
care providers, both inside and outside the ACO, to improve care
coordination for its assigned beneficiaries.
As we explained in the proposed rule, as a result of our experience
in reviewing these narratives, we have determined that while they can
be helpful to verify that the ACO has established the required
processes and defined patient-centeredness criteria prior to its entry
into the Shared Savings Program, the specific details of the processes
the ACO has established are not particularly important or relevant for
purposes of assessing whether the ACO is eligible to participate in the
program. In fact, ACOs have indicated that their initial plans for the
processes required under Sec. 425.112 as articulated in their program
application often change as a result of obtaining additional
information about their ACO participants' and ACO providers/suppliers'
processes and gaining additional experience during implementation of
the processes. We believe such improvements to ACO processes based on
program experience are reasonable to expect and should be encouraged.
First, under Sec. 425.112(b), ACOs are required to evaluate and
periodically update each process and as they do so, initially
implemented processes will necessarily change to accommodate lessons
learned. Moreover, once the ACO begins to request claims information
and other CMS data and to incorporate this information into its
operations, the ACO may discover that certain assumptions it made at
the time of application should be adjusted to maximally improve the
quality of care or cost efficiencies for the ACO's assigned population.
In rare instances, particularly in the early days of the program before
stakeholders fully understood the implications of program
participation, we found review of such narratives useful to understand
the level of an ACO's readiness for participation in the Shared Savings
Program. However, such narratives have not been particularly useful in
determining if the ACO meets the requirements for participation in the
Shared Savings Program. In a vast majority of cases, we now believe it
is sufficient that the ACO certify at the time of application that it
has defined the required processes and patient centeredness criteria
consistent with the requirements specified in section Sec. 425.112.
Therefore, we believe it would reduce burden for ACOs, without
compromising our ability to determine whether an ACO meets the criteria
for participation in the Shared Savings Program, to require that the
ACO certify that it meets the requirements in Sec. 425.112, and only
submit a narrative or other documentation describing how the ACO will
implement the required processes and patient-centeredness criteria upon
our request. Further, we do not anticipate that this change would have
a significant effect on beneficiaries receiving services from ACO
providers/suppliers because as noted earlier, we anticipate that ACOs
would update each process as they gain experience and, as they do so,
initially implemented processes that might have been reflected in the
narrative or other supporting documentation submitted with their
application would necessarily change to accommodate lessons learned.
Similarly, as part of the application process, the Shared Savings
Program regulations require the ACO to submit materials documenting the
ACO's organization and management structure, including an
organizational chart, a list of committees (including names of
committee members) and their structures, and job descriptions for
senior administrative and clinical leaders (Sec. 425.204(c)(1)(iii)).
As we indicated in the proposed rule, we have found the organizational
chart useful for purposes of evaluating if an ACO meets eligibility
requirements, and anticipate continuing to request this chart from
applicants; however, we have found that further detail including lists
of committees and job descriptions for senior administrative and
clinical leaders have not added particular value to our review and
approval of applications. Moreover, the receipt of such materials as
part of the ACO's application has not significantly impacted our
ability to determine whether the ACO meets the requirements regarding
leadership and management in Sec. 425.108. We believe, on balance,
that our need for such detailed information from all applicants is
outweighed by our desire to reduce application burden. In particular
circumstances where additional information would aid our review, we
believe our need for such detailed information can be reasonably met by
requiring applicants to submit such materials upon our request. As a
result, we believe it would be less burdensome for us to require ACO
applicants to certify that, for example, they meet the leadership and
management requirements found at Sec. 425.108 rather than requiring
all ACO applicants to submit detailed materials (such as job
descriptions) or narratives about the ACO's committees and leadership.
While we do not anticipate having to routinely request such
materials to supplement our review and approval of ACO applications to
participate in the Shared Savings Program, we explained in the proposed
rule that we believe it is important to retain the discretion to do so
in limited cases where such detail could be useful. Therefore, we
proposed to make revisions to our application requirements as discussed
in the proposed rule (82 FR 34117 through 34120). We also noted that in
cases
[[Page 53221]]
where an ACO is requested to submit additional material for review in
conjunction with its application, and we find that the material is
inconsistent with program requirements, then we may deny the ACO's
application. Similarly, if we discover an inconsistency after the ACO
has already been approved to participate in the program, the ACO may be
subject to the pre-termination actions set forth in Sec. 425.216,
termination under Sec. 425.218, or both.
In the proposed rule, we also explained that we do not believe it
is necessary for ACO applicants to submit narratives describing how
they would distribute shared savings payments or how the proposed plan
would achieve the specific goals of the Shared Savings Program and the
general aims of better care for individuals, better health for
populations, and lower growth in expenditures, as required by Sec.
425.204(d). Based on our experience, such narratives have not been
useful in determining if the ACO meets requirements for participation
in the program or whether an ACO's application should be approved. We
believe it would be more useful to us and less burdensome for ACOs if
we were instead to require that, an ACO, as part of its application to
participate in the Shared Savings Program, certify that it has a method
and plan to receive shared savings payments and to distribute those
payments to its ACO participants and ACO providers/suppliers, as
required by the statute. We note, however, that we continue to believe
it is useful to stakeholders to know how various ACOs have chosen to
use or distribute the shared savings they earn. Therefore, we indicated
that in the interest of transparency, we will continue to require ACOs
to publicly report information on their dedicated Web pages about their
shared savings and shared losses, including information about the total
proportion of shared savings invested in infrastructure, redesigned
care processes, and other resources to support the three-part aim goals
of better health for populations, better care for individuals, and
lower growth in expenditures, including the proportion distributed
among ACO participants, as required under Sec. 425.308(b)(4).
In light of our experience with the review of the documentation
submitted as part of the ACO's initial application, we proposed several
modifications to our requirements for document submission. We proposed
to retain all requirements related to ACO eligibility criteria and
public reporting, as currently specified under the Shared Savings
Program regulations. However, to reduce application burden without
compromising our ability to evaluate applications effectively for
compliance with Shared Savings Program requirements, we proposed to
modify certain sections of our regulations that require ACOs to submit
supporting materials and documentation at the time of application.
Instead of requiring submission of certain materials, narratives, or
supporting documentation, we proposed to require ACOs to certify that
they meet the applicable eligibility and documentation requirements as
specified under our program rules. At the same time, we recognized that
there have been instances when the review of supporting documentation
and/or narratives has been helpful in making a determination about an
ACO's eligibility for participation in the program. Therefore, although
we proposed to eliminate the general requirement that ACOs submit
certain documentation as part of their initial application to
participate in the Shared Savings Program, we proposed to retain the
right to request the submission of supporting materials and
documentation in cases when such additional information would be useful
in making a determination regarding the ACO's application. We indicated
that we believe that this proposed modification to the regulations
governing ACO applications would introduce additional flexibility that
would reduce the level of burden inherent in the Shared Savings Program
application process while also ensuring we are still able to
appropriately evaluate an ACO's eligibility for program participation.
Accordingly, in order to reduce application burden while retaining
flexibility to obtain additional documentation when necessary to
determine ACO eligibility and compliance with program rules, we
proposed to remove the requirements in Sec. Sec. 425.204(c)(1) and
(d), 425.112(a)(3)(i) and (ii), and 425.112(b)(4)(ii) for the
submission of certain specified documents and narratives as part of an
ACO's application to participate in the Shared Savings Program.
Specifically, we proposed to revise Sec. 425.204(c)(1) to require an
ACO, as part of its application, to certify that it satisfies the
Shared Savings Program requirements and to submit, upon CMS request,
supporting materials (including narratives) and documentation
demonstrating that the ACO satisfies program requirements indicated in
proposed revised Sec. 425.204(c). Additionally, we proposed to revise
Sec. 425.204(d) to indicate that the ACO must certify, as part of its
application to participate in the Shared Savings Program, that it has a
mechanism and plan to receive and use payments for shared savings,
including criteria for distributing shared savings among its ACO
participants and ACO providers/suppliers. We also proposed to make a
conforming change to remove paragraphs (d)(1) through (3) of Sec.
425.204, which relate to the submission of narratives related to the
ACO's use of shared savings payments. This proposal did not include a
requirement that the ACO submit information regarding its mechanism and
plan for receiving and using shared savings upon request. As explained
in the proposed rule, we do not intend to request this information as
part of the application process because in our experience, how an ACO
intends to use or distribute shared savings has not been a relevant
consideration during any application cycle to determine whether the ACO
has met the eligibility requirements to participate in the Shared
Savings Program. However, we noted that we continue to believe that
information on how an ACO uses and distributes its shared savings is
useful for the public, and therefore ACOs will continue to be required
to publicly report this information under Sec. 425.308(b)(4)(ii).
We also proposed similar changes to the requirements in Sec.
425.112(a)(3)(i), (a)(3)(ii), and (b)(4)(ii) to remove references to
the submission of narratives to explain or describe how the ACO will
implement the required elements of the ACO's care processes and
patient-centeredness criteria. ACOs must still implement these care
processes and adopt a focus on patient-centeredness; however, we
proposed that they would no longer need to submit descriptions of how
they will satisfy these requirements as part of their initial
application. We noted, however, that ACOs may still be required to
submit upon request a description or documentation sufficient to
describe how the ACO will implement the required processes and patient-
centeredness criteria found at Sec. 425.112 because under the proposed
revisions to Sec. 425.204(c)(1)(ii), CMS would retain the discretion
to request such documentation from the ACO at any time.
In summary, we stated that we believe these modifications to the
application requirements will significantly reduce the burden of
applying to participate in the Shared Savings Program without reducing
our ability to ensure that applicants meet the established
[[Page 53222]]
eligibility requirements. Rather than requiring every applicant to
submit detailed supporting documents or narratives for all of these
requirements, we would instead request supporting documents or
narratives only if additional information is needed in order to fully
assess an ACO's application before making a decision to approve or deny
the application. Further, we did not anticipate that the proposed
modifications to our application requirements would have any effect on
beneficiaries receiving care from providers and suppliers participating
in the Shared Saving Program, nor did we believe that the proposed
changes would affect our program integrity efforts, because we would
retain discretion to request such information (and more targeted and
appropriate information) as needed. We sought comment on these
proposals and on additional ways to reduce burden in the application
process.
Comment: Commenters generally expressed widespread support for the
proposals related to reducing application burden. However, a few
commenters, including some beneficiary advocates, expressed significant
concerns about the proposal to remove the requirement that ACOs submit
documentation related to patient-centeredness as part of their
applications, stating, for example: ``We believe that it is imperative
that ACOs be held to the highest possible standard for patient-
centeredness.'' These commenters encouraged CMS to explore alternatives
to reduce application burden. One of these commenters suggested that
CMS require an ACO applicant to submit any existing care processes,
along with a description of its capacity and strategy for evaluating
and updating these processes. This commenter agreed that it is
important for CMS to retain the right to request additional
documentation at any time. Another commenter stated a belief that
removing the application narratives ``violates the spirit of the MSSP
ACO model'' and stated that the inclusion of such narratives in the
application supports care improvement activities by emphasizing the
importance of the applicant's planning and introspection about its care
processes.
Another commenter expressed concern that in the absence of the
submission of narratives describing required processes and a rigorous
evaluation by CMS, all health systems would be assessed solely based on
cost savings and administration. The commenter was concerned that
absent a requirement for ACOs to detail how they intend to implement
the required processes, a world-class, integrated health care system
would, on paper, look the same as a system that had not undertaken
improvement activities. Similarly, another commenter noted, ``we are
concerned that replacing the narrative with a certification may result
in some program applicants simply checking the box to say that they
have these processes which contain critical patient protections without
actually considering whether the ACO is prepared to implement them in
the context of the Shared Savings Program.''
Response: We agree that ACOs should be held to the highest possible
standard for patient-centeredness, however, we respectfully disagree
that the requirement, as part of the application, to submit a narrative
detailing the ACO's plans for developing patient-centered processes
accomplishes this goal. We believe that other program elements, like
the patient experience of care survey measures used to assess ACO
quality performance and our internal monitoring of utilization, are
better indicators of how well ACOs are meeting patient-centeredness
criteria. We intend to continue assessing and monitoring ACO
performance regarding patient-centeredness and the other required care
processes. In addition, we note that under the proposed changes to the
application requirements, which we are finalizing in this rule, we
retain the flexibility to request submission of various narratives and
documentation when this additional information is needed to fully
assess the ACO's application. We will continue to consider whether
review of certain narratives would help support Shared Savings Program
goals, and will consider whether it would add value to our ACO
application review process to request a more refined or targeted
narrative related to patient-centeredness and the other required care
processes.
Comment: A commenter representing physician specialists raised
concerns about the proposal to no longer require Shared Savings Program
applicants to submit narratives describing how they would distribute
shared savings payments. The commenter suggested that CMS should
require ACOs to distribute shared savings to ACO providers/suppliers.
Another commenter questioned how CMS would know if the ACO followed the
plan it set forth if CMS no longer required the ACOs to provide details
about how any shared savings would be distributed at the outset via
their application.
Response: We respectfully disagree with the commenters who believe
it is necessary for Shared Savings Program applicants to continue to
submit narratives describing how they would distribute shared savings
payments in order to permit us to review and approve an ACO's
eligibility to participate in the program. We believe it is appropriate
for ACOs to continue to have the freedom to choose how to distribute or
otherwise use any shared savings they earn, within the confines of the
agreements they make with ACO participants and ACO providers/suppliers.
Furthermore, we believe it is the responsibility of the parties signing
those agreements to understand and enforce the terms of the agreement.
We note, however, that we are maintaining the requirement for ACOs to
publicly report on how they use and distribute their shared savings and
we intend to continue to monitor ACO adherence to that requirement.
We are finalizing the policies in this section as proposed.
Specifically, we are finalizing our proposals to: (1) Remove the
requirements in Sec. Sec. 425.204(c)(1) and (d), 425.112(a)(3)(i) and
(ii), and 425.112(b)(4)(ii) for the submission of certain specified
documents and narratives as part of an ACO's application to participate
in the Shared Savings Program; (2) revise Sec. 425.204(d) to indicate
that the ACO must certify, as part of its application to participate in
the Shared Savings Program, that it has a mechanism and plan to receive
and use payments for shared savings; (3) make a conforming change to
remove paragraphs (d)(1) through (3) of Sec. 425.204, which relate to
the submission of narratives related to the ACO's use of shared savings
payments; and (4) make similar changes to the requirements in Sec.
425.112(a)(3)(i), (a)(3)(ii), and (b)(4)(ii) to remove references to
the submission of narratives.
4. Addressing Compliance With ACO Participant TIN Exclusivity
Requirement
a. Background
Under the Shared Savings Program, ACO participant TINs are not
required to be exclusive to one Shared Savings Program ACO unless the
TIN submits claims for primary care services used to determine the
ACO's assigned population (Sec. 425.306(b)). The purpose behind this
requirement is to ensure that we are able to assign a unique set of
beneficiaries to each ACO participating in the Shared Savings Program.
Therefore, as part of the Shared Savings Program application process
and upon an ACO's request to add an ACO participant TIN, we check the
TIN against all other Shared Savings Program ACO participant lists. If
the
[[Page 53223]]
TIN appears on the ACO participant list of one or more other ACOs, the
TIN is considered to be ``overlapping.'' We then determine whether the
overlap is permissible under our program rules. If the overlap is not
permissible (because the TIN has a history of billing for primary care
services used in our assignment methodology) then we require the ACO
that is seeking to add the TIN to its ACO participant list to rectify
the overlap by the deadline we have established for making changes to
the next performance year's ACO participant list. If the overlap is
permissible (because the TIN does not have a history of billing for
primary care services used in our assignment methodology) then the ACO
participant TIN can be approved to be an ACO participant in more than
one ACO for the performance year. Each time we run the assignment
algorithm during the course of the performance year, we monitor
overlaps to ensure that the overlaps continue to be in compliance with
Sec. 425.306(b).
In a few instances, we have discovered that ACO participant TINs
that have been approved to participate in multiple ACOs subsequently
began billing for primary care services used in assignment during a
benchmark or performance year. Although our program rules permit us to
take compliance action against ACOs for violations of Shared Savings
Program requirements, they do not specifically address what compliance
actions we would impose on ACOs in instances where an ACO participant
falls out of compliance with the requirement in Sec. 425.306(b)(2)
that an ACO participant TIN that submits claims for primary care
services used in assignment be exclusive to a single ACO during a
benchmark or performance year, or when non-compliance with this
requirement is discovered during the 3-month claims runout for a
benchmark or performance year. Moreover, the program rules do not
address what modifications to our assignment methodology could be made
to account for this overlap.
We believe it is important for ACOs, ACO participants, and ACO
providers/suppliers to have updated and accurate information regarding
their participation status in the Shared Savings Program. For example,
participation in a Shared Savings Program ACO has implications for ACO
providers/suppliers under the new Quality Payment Program (see 81 FR
80496 through 80501). The Quality Payment Program replaces a patchwork
system of Medicare programs with a flexible system that allows eligible
clinicians to choose from two paths that link payments to quality: MIPS
and participation in Advanced APMs. The Quality Payment Program,
through MIPS and the APM incentive, will impact eligible clinicians'
payments beginning in payment year 2019 based on 2017 reporting.
Under the CY 2017 Quality Payment Program final rule with comment
period, eligible clinicians participating in Advanced APMs (including
Tracks 2 and 3 under the Shared Savings Program) may become Qualifying
APM Participants and receive a 5 percent APM Incentive Payment if they
have a sufficient percentage of payments for Part B covered
professional services, or a sufficient percentage of Medicare patients
that are attributable to services furnished through an Advanced APM for
a given performance year. In addition to earning a 5 percent APM
Incentive Payment, Qualifying APM Participants are not subject to the
MIPS reporting requirements and payment adjustment for a given
performance year. As a result, revisions to ACO participant lists that
occur mid-year or following the end of a benchmark or performance year
could have widespread implications not only for the ACO, but also for
its ACO providers/suppliers under the Quality Payment Program.
b. Proposals
As participation in the Shared Savings Program grows and more ACOs
and ACO participants join the program, we believe overlapping TINs are
likely to become more common. We also believe that changes to our
program rules regarding the claims that will be considered in assigning
FFS beneficiaries to an ACO (specifically, the policy finalized in the
June 2015 final rule to exclude services furnished by several physician
specialty types from the assignment methodology) may result in a
greater number of permissible ACO participant TIN overlaps (see 80 FR
32753 and 32754). As a result, we anticipate there could also be an
increased number of cases where ACO participant TINs with initially
permissible overlaps could become out of compliance with the
requirement at Sec. 425.306(b)(2) that an ACO participant TIN be
exclusive to a single Shared Savings Program ACO if the TIN bills for
primary care services that are used to assign beneficiaries to the ACO.
This could occur, for example, if a group practice that initially
includes only physician specialty types whose services are excluded
from the assignment methodology were to subsequently employ a non-
physician practitioner who bills for primary care services. We believe
these types of practice arrangements are becoming increasingly common.
Therefore, as we stated in the proposed rule, we believe it is
necessary to streamline our approach to handling such situations in
order to reduce the burden and uncertainty for ACOs when changes in ACO
participant billing practices result in an ACO participant falling out
of compliance with the exclusivity requirement at Sec. 425.306(b)(2).
Rather than the current policy under which an ACO may be required to
remove an overlapping ACO participant and recertify its ACO participant
list for the performance year (thus necessitating redetermination of
beneficiary assignment and delays in or revisions to benchmark or
performance year calculations), we believe it would be less disruptive
for ACOs if we were to permit overlapping TINs that begin billing for
services used in assignment during a benchmark or performance year
(including claims for services furnished during the benchmark of
performance year, but submitted during the 3-month claims runout) to
remain on the ACO participant lists for all affected ACOs for the
remainder of the performance year in which we determine that an overlap
exists. For example, assume that, based on an analysis of claims for
services furnished in performance year 2018, we were to identify an
impermissible overlapping TIN in January 2019 after the ACO participant
lists for performance year 2019 had already been certified. Under this
proposal, the TIN would be able to remain on the ACO participant lists
of all affected ACOs for the 2018 performance year as well as the
remainder of performance year 2019. To ensure that an overlapping TIN
is not inadvertently used in the assignment algorithm for multiple ACOs
when determining where a beneficiary received the plurality of primary
care services, which could result in assignment of the same beneficiary
to multiple ACOs, we proposed to simply exclude any claims for services
furnished by the overlapping TIN from the assignment methodology when
conducting final beneficiary assignment for any benchmark or
performance year in which the TIN bills Medicare for services used in
our assignment methodology. The affected ACOs would be required to
resolve the overlap prior to recertification of their ACO participant
lists for the subsequent performance year. If the overlap remains
unresolved when the ACOs certify their ACO participant lists for the
next
[[Page 53224]]
performance year, we would remove the TIN from the ACO participant
lists of all ACOs seeking to include the TIN, in accordance with our
current policy for resolving overlaps. For example, in the hypothetical
case above, if the overlap were to remain unresolved when the ACOs
certify their ACO participant lists for performance year 2020, we would
remove the TIN from the ACO participant lists for all ACOs seeking to
include the TIN as an ACO participant for performance year 2020.
Therefore, we proposed to modify our program rules in Sec. 425.306
and subpart E of part 425 to address this issue. We proposed to modify
Sec. 425.306(b) to indicate that if, during a benchmark or performance
year (including the 3-month claims run out period for such benchmark or
performance year), an ACO participant that participates in more than
one ACO begins billing for services that would be used in assignment,
we would not consider any services billed through that TIN when
performing beneficiary assignment for the applicable benchmark or
performance year. We also proposed to eliminate the reference to
``primary care'' in Sec. 425.306(b)(2) when describing the services
used to determine the ACO's assigned beneficiary population to conform
with our proposal to implement section 17007 of the 21st Century Cures
Act under which we would consider all services furnished in RHCs and
FQHCs in the assignment methodology starting in the 2019 performance
year. In addition, the ACOs in which the overlapping TIN is an ACO
participant may be subject to compliance action (as provided under
Sec. 425.216) or termination under Sec. 425.218. Compliance actions
may include requiring each ACO that includes the TIN as an ACO
participant to submit a corrective action plan explaining how the ACO
plans to work with the overlapping ACO participant to resolve the
overlap for the next performance year. If the overlap remains
unresolved by the date specified by us in our request for a corrective
action plan, we would remove the overlapping ACO participant TIN from
the ACO participant list of each ACO for the subsequent performance
year.
We also proposed to revise our general assignment methodology at
Sec. 425.400(a)(1) to add new paragraph (a)(1)(iii) to indicate that
when we determine final assignment after the end of each benchmark or
performance year, we will exclude claims for services furnished during
the benchmark or performance year by an ACO participant that
participates in more than one ACO. We stated that we believe that this
policy will ensure a uniquely assigned beneficiary population for each
ACO and prevent the same beneficiaries from being included in
determining benchmark or performance year expenditures for more than
one ACO.
Comment: Commenters were nearly all supportive of our proposed
changes to our policies for addressing situations in which an
overlapping ACO participant TIN begins billing for services that are
used in beneficiary assignment during a benchmark or performance year.
However, some commenters stated that our proposal to exclude all claims
for services furnished by an overlapping ACO participant from the
assignment methodology was overbroad and that such exclusions should be
limited to instances in which there is a significant overlap. For
example, one commenter recommended that CMS only exclude a TIN if the
primary care services are billed over an extended period, for example,
for more than one-half of the performance year.
Response: We appreciate receiving the comments in support of this
proposal and the other thoughtful comments. We do not believe it would
be appropriate to exclude a TIN only if the services used in assignment
are billed during more than one-half of the performance year or if the
overlap is otherwise significant. Such approaches would not ensure a
uniquely assigned beneficiary population for each ACO and, therefore,
the same beneficiaries could inappropriately be included in determining
benchmark or performance year expenditures for more than one ACO.
Based on a review of the comments, we believe that finalization of
the proposed policies will ensure that we are able to continue to
assign a unique set of beneficiaries to each ACO participating in the
Shared Savings Program and avoid making duplicate shared savings
payments for ACOs with TINs that participate in more than one ACO,
while preserving the flexibility that is currently extended to ACO
participants that do not bill for services used in assignment, and
recognizing the possibility for mid-year changes in care and billing
practices by these ACO participants. We believe that implementing the
proposed changes to our process for addressing ACO participant overlaps
will improve ACO and ACO participant understanding of our policies and
requirements regarding ACO participant exclusivity, while also reducing
burden for ACOs that currently must recertify their ACO participant
lists and may be subject to retrospective modifications or delays in
assignment and other related benchmark or performance year
calculations. Additionally, for purposes of the Quality Payment
Program, ACO participant TINs and the eligible clinicians that bill
through those TINs will have greater certainty regarding whether they
qualify as participating in an APM or Advanced APM for a performance
year. Under the proposed policy, which we are finalizing, an ACO
participant will know for the entire performance year with certainty
that it is participating in a particular APM (or Advanced APM) entity.
Comment: A commenter suggested that CMS alert ACOs when there is a
provider or supplier identified as participating in more than one ACO
so that both ACOs and the affected provider/supplier have an
opportunity to correct the issue.
Response: Each time we run the assignment algorithm during the
performance year, we monitor overlaps to ensure that the overlaps
continue to be in compliance with Sec. 425.306(b). We notify
stakeholders when overlaps occur and require them to make appropriate
corrections. Additionally, ACO participant list information is made
publicly available at https://data.cms.gov. ACOs can use the Medicare
Shared Savings Program ACO Participants data sets to identify allowable
overlaps annually. The data sets also allow an ACO to verify whether
TINs joining their ACO have the same legal business name as a TIN
already participating in an ACO.
Comment: A few commenters expressed general concerns regarding the
assignment process as it relates to services furnished by specialists.
Response: While these comments were beyond the scope of the
proposed rule, we expect to continue to consider and refine the claims-
based assignment process over time, and will take into consideration
the important role played by specialty practices when assessing any
potential changes to our assignment methodology.
We are finalizing the proposed changes to our policies for
addressing compliance with the ACO participant TIN exclusivity
requirement as proposed. Specifically, we are finalizing our proposals
to: (1) Modify Sec. 425.306(b) to indicate that if, during a benchmark
or performance year (including the 3-month claims run out period for
such benchmark or performance year), an ACO participant that
participates in more than one ACO begins billing for services that
would be used in assignment, we would not consider any services billed
through that TIN when performing beneficiary assignment for the
applicable benchmark or
[[Page 53225]]
performance year; (2) eliminate the reference to ``primary care'' in
Sec. 425.306(b)(2) when describing the services used to determine the
ACO's assigned beneficiary population; and (3) revise our general
assignment methodology at Sec. 425.400(a)(1) to add new paragraph
(a)(1)(iii) to indicate that when we determine final assignment after
the end of each benchmark or performance year, we will exclude claims
for services furnished during the benchmark or performance year by an
ACO participant that participates in more than one ACO.
5. Treatment of Individually Beneficiary Identifiable Payments Made
Under a Demonstration, Pilot, or Time Limited Program
a. Background
Under section 1899(d) of Act, ACOs participating in the Shared
Savings Program are accountable for the total Parts A and B costs for
the Medicare FFS beneficiaries assigned to the ACO. Therefore, in
addition to Medicare Parts A and B claims, we include non-claims based
individually beneficiary identifiable payments made from the Medicare
Trust Funds when performing financial calculations for the Shared
Savings Program, including establishing, adjusting, and updating
financial benchmarks and calculating performance year expenditures. We
internally track these non-claims based beneficiary identifiable
payments through a separate CMS system that receives and stores these
non-claims based payments made from the Medicare Trust Funds under a
demonstration, pilot or time limited program.
To date, when we perform ACO benchmarking and financial
calculations under the Shared Savings Program, we have included (in
addition to all Medicare Parts A and B claims) all non-claims based
individually beneficiary identifiable payments for the applicable
benchmark or performance year that are included in the separate CMS
system, including any payments made during the 3-month claims run-out
period for the benchmark or performance year. This means that to date
we have included in the calculation of historical benchmarks and
performance year expenditures some interim payments made under a
demonstration, pilot, or time limited program that will be subject to
subsequent reconciliation to determine the final payment amount.
However, because the various demonstrations, pilots, or time limited
programs may have different operational schedules from the Shared
Savings Program, it is not possible for us to include all interim and
final beneficiary identifiable payments made under these initiatives in
benchmarking and financial reconciliation calculations for the Shared
Savings Program; and, as a result, these calculations have excluded
some interim and final non-claims based beneficiary identifiable
payments made under certain demonstrations, pilots, or time limited
programs. For example, because of the timing and availability of BPCI
non-claims based payment amounts, to date we have included only up to
two quarters of interim payment data for BPCI in ACO benchmarking and
financial reconciliation calculations for the Shared Savings Program
and no final payment amounts.
To date, non-claims based individually beneficiary identifiable
payments represent a relatively minor proportion of an ACO's total Part
A and B beneficiary expenditure amounts as determined under the Shared
Savings Program (mean of 0.09 percent overall impact of ACO non-claims
based payments on total per capita expenditures and a mean of 137
person-years in an ACO's assigned beneficiary population with a non-
claims based payment during the year; minimum -0.72 percent, 0 person-
years; maximum 1.24 percent, 1,865 person-years). For the
demonstrations, pilots, or time limited programs that include interim
and final reconciliations, the impact of including the non-claims based
payments could be positive or negative for an ACO for a given
performance year. Additionally, a preliminary analysis suggests that
interim payments made under select demonstrations, pilots, or time
limited programs fluctuate on a quarterly basis. We refer the reader to
the proposed rule (82 FR 34122 through 34123) for further details about
the results of this analysis.
Fluctuations in the non-claims based payments for certain
initiatives, such as BPCI, have generated stakeholder concern. Further,
stakeholders note that the impact of including interim payments in
financial calculations may become greater in the future, given the
increasingly widespread interest in participation in alternative
payment models and the growing number of such models being tested
through the CMS Innovation Center. Stakeholders have therefore
suggested that we should revise our policies to clarify that only final
non-claims based payments made within the 3 months claims run out
period under a demonstration, pilot, or time limited program will be
included in the calculation of an ACO's benchmark and performance year
expenditures.
b. Proposals
Our preliminary analysis, as discussed in the background section,
suggests that interim non-claims based payments (that is, payments that
are subject to reconciliation at a later date) made under a
demonstration, pilot, or time limited program can fluctuate
significantly from quarter to quarter and may not reflect the actual
final reconciled payment amount. Thus, as we stated in the proposed
rule, we agree with the stakeholders who have suggested that only final
non-claims based payments made under a demonstration, pilot, or time
limited program should be included in financial calculations related to
benchmarks and performance year expenditures under the Shared Savings
Program. We believe this would be a reasonable approach to determining
Parts A and B expenditures for assigned beneficiaries for both
benchmark and performance years given the uncertain impact of including
interim payments that are subject to further reconciliation on
financial calculations for the Shared Savings Program. We also agree
that use of interim payments made under a demonstration, pilot, or time
limited program could have an increasingly large effect on ACO
benchmarks and performance year expenditure calculations in the future
given widespread stakeholder interest in participating in alternative
payment models and CMS interest in testing and expanding additional
payment models that may lead to higher quality and more coordinated
care at a lower cost to Medicare.
Therefore, we proposed to modify our regulations at Sec. Sec.
425.602(a)(1)(ii), 425.603(c)(1)(ii), and 425.603(e)(2)(ii) to add new
provisions to indicate that, (1) when establishing benchmarks for
agreement periods beginning before 2018, we will include all
individually beneficiary identifiable payments, including interim
payments, made under a demonstration, pilot, or time limited program,
(2) for agreement periods beginning in 2018 and subsequent years, we
would only include individually beneficiary identifiable payments made
under a demonstration, pilot, or time limited program that are final
and not subject to further reconciliation, and (3) for the 2018
performance year and subsequent performance years in agreement periods
beginning in 2015, 2016, and 2017, the benchmark would be adjusted to
reflect only individually beneficiary identifiable final payments made
under
[[Page 53226]]
a demonstration, pilot, or time limited program. Additionally, we
proposed to add new Sec. Sec. 425.604(a)(6)(ii)(A),
425.606(a)(6)(ii)(A) and 425.610(a)(6)(ii)(A) indicating that when
calculating expenditures for performance years before 2018, we will
include all individually beneficiary identifiable payments, including
interim payments, made under a demonstration, pilot, or time limited
program. We also proposed to add new Sec. Sec. 425.604(a)(6)(ii)(B),
425.606(a)(6)(ii)(B) and 425.610(a)(6)(ii)(B) indicating that when
calculating expenditures for performance year 2018 and subsequent
performance years, we would only include individually beneficiary
identifiable payments made under a demonstration, pilot, or time
limited program that are final and not subject to further
reconciliation. To be consistent with our treatment of claims-based
payments, such final payments would have to be available in the
separate CMS system by the end of the 3-month claims run out period.
We invited comments on this proposal.
Comment: We received few comments on this proposal. Those that
commented were supportive, agreeing that the proposed approach would
appropriately help reduce fluctuations in payment amounts from quarter
to quarter. A few commenters suggested that interim payments provide a
``signal to final payments.'' In lieu of removing interim payments from
our financial calculations, these commenters requested that CMS
indicate the amounts of interim and final beneficiary identifiable
payments made under demonstrations, pilots or other time-limited
programs in the ACO financial reports.
Response: We appreciate the comments in support of this proposal.
We continue to believe that our proposal to include only final payments
made under a demonstration, pilot or time limited program is a
reasonable approach to determining Parts A and B expenditures for
assigned beneficiaries for both benchmark and performance years given
the uncertain impact on ACOs' financial calculations of including
interim payments that will be subsequently revised to reflect the final
reconciled payment amounts. We are exploring improvements to feedback
reports and data files provided to ACOs to increase program
transparency. We appreciate the suggestions regarding including
payments under a demonstration, pilot, or time limited program in the
financial reports, and we will take them under advisement as we work to
further refine the reports.
We are finalizing the policies in this section as proposed, with
the exception of a minor revision to Sec. 425.603(e)(2)(ii)(C) to
address a technical error that was made in the proposed rule. In the
proposed rule, we inadvertently included a reference to the benchmark
in the proposed regulatory text for this provision. However, Sec.
425.603(e) establishes the policies for determining risk adjusted
county fee-for-service expenditures, which are used in calculating an
ACO's regional fee-for-service expenditures. In this final rule, we are
revising the language at Sec. 425.603(e)(2)(ii)(C) to correct this
reference.
I. Value-Based Payment Modifier and Physician Feedback Program
1. Overview
Section 1848(p) of the Act requires the establishment of a value-
based payment modifier (VM) that applies to specific physicians and
groups of physicians the Secretary determines appropriate starting
January 1, 2015, and to all physicians and groups of physicians by
January 1, 2017. On or after January 1, 2017, section 1848(p)(7) of the
Act provides the Secretary discretion to apply the VM to eligible
professionals (EPs) as defined in section 1848(k)(3)(B) of the Act.
Section 1848(p)(4)(C) of the Act requires the VM to be budget neutral.
The VM and Physician Feedback programs continue our initiative to
recognize and reward clinicians based on the quality and cost of care
provided to their patients, increase the transparency of health care
quality information and to assist clinicians and beneficiaries in
improving medical decision-making and health care delivery. As stated
in the CY 2016 PFS final rule with comment period (80 FR 71277), the
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L.
114-10) was enacted on April 16, 2015. Under section 1848(p)(4)(B)(iii)
of the Act, as amended by section 101(b)(3) of MACRA, the VM shall not
be applied to payments for items and services furnished on or after
January 1, 2019. Section 1848(q) of the Act, as added by section 101(c)
of MACRA, establishes the Merit-based Incentive Payment System (MIPS)
that shall apply to payments for items and services furnished on or
after January 1, 2019.
2. Overview of Existing Policies for the VM
In the CY 2013 PFS final rule with comment period, we discussed the
goals of the VM and also established that specific principles should
govern the implementation of the VM (77 FR 69307). We refer readers to
that rule for a detailed discussion. In the CY 2013 PFS final rule with
comment period (77 FR 69310), we also finalized policies to phase-in
the VM by applying it beginning January 1, 2015, to Medicare PFS
payments to physicians in groups of 100 or more EPs. A summary of the
existing policies that we finalized for the CY 2015 VM can be found in
the CY 2014 PFS proposed rule (78 FR 43486 through 43488).
Subsequently, in the CY 2014 PFS final rule with comment period (78 FR
74765 through 74787), we finalized policies to continue the phase-in of
the VM by applying it starting January 1, 2016, to payments under the
Medicare PFS for physicians in groups of 10 or more EPs. Then, in the
CY 2015 PFS final rule with comment period (79 FR 67931 through 67966),
we finalized policies to complete the phase-in of the VM by applying it
starting January 1, 2017, to payments under the Medicare PFS for
physicians in groups of 2 or more EPs and to physician solo
practitioners. In the CY 2016 PFS final rule with comment period (80 FR
71277 through 71279), we finalized that in the CY 2018 payment
adjustment period, the VM will apply to non-physician EPs who are
physician assistants (PAs), nurse practitioners (NPs), clinical nurse
specialists (CNSs), and certified registered nurse anesthetists (CRNAs)
in groups with 2 or more EPs and to PAs, NPs, CNSs, and CRNAs who are
solo practitioners.
In the CY 2016 PFS final rule with comment period (80 FR 71280), we
adopted a two-category approach for the CY 2018 VM based on
participation in the PQRS by groups and solo practitioners. For the
purposes of the CY 2018 VM, Category 1 includes the following groups
and solo practitioners:
(1) Groups that meet the criteria to avoid the CY 2018 PQRS payment
adjustment as a group practice participating in the PQRS GPRO;
(2) Groups that have at least 50 percent of the group's EPs meet
the criteria to avoid the PQRS payment adjustment for CY 2018 as
individuals;
(3) Solo practitioners that meet the criteria to avoid the CY 2018
PQRS payment adjustment as individuals; and
(4) Groups and solo practitioners that meet the criteria to avoid
the CY 2018 PQRS payment adjustment through participation in a Shared
Savings Program ACO, if the ACO in which they participate successfully
reports quality data as required by the Shared Savings Program.
[[Page 53227]]
Category 2 includes those groups and solo practitioners that are
subject to the CY 2018 VM payment adjustment and do not fall within
Category 1. Groups in Category 1 have been eligible to receive upward,
neutral, or downward adjustments under our quality-tiering methodology,
and groups and solo practitioners in Category 2 receive an automatic
downward adjustment under the VM.
In the CY 2016 PFS final rule with comment period (80 FR 71288 to
71291), we finalized that we will apply the following adjustments to
payments, for items and services furnished under the Medicare PFS in CY
2018, to physicians, PAs, NPs, CNSs, and CRNAs in groups with 10 or
more EPs and at least one physician:
Negative 4 percent (-4.0 percent) for those that fall into
Category 2.